Biosimilars/Research

Economic considerations for biosimilars in the US

Biosimilars/Research | Posted 19/04/2019

Smeeding and colleagues explore cost considerations related to biosimilars in the US, and present a broad perspective on value beyond price reduction in a recent review.

Biosimilar drug packaging does not meet EU guidelines on readability

Biosimilars/Research | Posted 19/04/2019

Analysis of 35 biosimilar medicines licensed by the European Medicines Agency (EMA) finds packaging to be more complex than recommended. None of the packaging leaflets analysed were found to be ‘easy to understand’, with sections on therapeutic indication and side effects found to be the most complex [1].

Efficacy and safety of bevacizumab biosimilar ABP 215

Biosimilars/Research | Posted 12/04/2019

Authors from the US and Europe report data from a phase III study comparing the clinical efficacy and safety of the bevacizumab biosimilar ABP 215 (Mvasi) with originator bevacizumab Avastin in patients with advanced non-squamous non-small cell lung cancer (NSCLC) [1].

Key considerations for biosimilars in the US

Biosimilars/Research | Posted 12/04/2019

Key considerations regarding biosimilars for payers in the US are discussed in a recent review [1]. The authors explore factors promoting the uptake of biosimilars, interchangeability and naming considerations, and challenges to uptake.

Impact of proposed changes to FDA approach to biosimilars

Biosimilars/Research | Posted 08/03/2019

In the Opinion article, Professor Sarfarez Niazi urges the US Food and Drug Administration (FDA) to make adjustments to its guidance on biosimilar development [1]. Niazi’s proposals are consistent with the anti-regulatory political rhetoric and administrative actions that are becoming increasingly widespread in the US. In this article, Professor Pekka Kurki comments on some of Niazi’s proposals from a global perspective [2].

ESMO survey highlights need for education and alignment

Biosimilars/Research | Posted 05/04/2019

The results of a survey carried out by the European Society for Medical Oncology (ESMO) on biosimilars understanding in oncologists have highlighted the need for education and worldwide alignment [1].

Phase III clinical trials started for adalimumab biosimilars

Biosimilars/Research | Posted 05/04/2019

Phase III clinical trials have been started for adalimumab biosimilars from Alvotech and Celltrion.

How can EU policymakers access the potential of biosimilars

Biosimilars/Research | Posted 01/04/2019

Policymakers in Europe should introduce a long-term, multi-stakeholder framework to realize the full potential of off-patent biologicals and biosimilar drugs, according to the results of a series of roundtable discussions held with clinicians, government bodies and industry representatives [1].

Comparison of autoinjectors for inflammatory joint or bowel disease

Biosimilars/Research | Posted 01/04/2019

Imraldi is a biosimilar of the antitumour necrosis factor (TNF) monoclonal antibody adalimumab. It was approved in Europe in August 2017 for the treatment of various inflammatory conditions [1].

Clinician biosimilar prescribing habits and need for education

Biosimilars/Research | Posted 22/03/2019

At present, biosimilar prescribing and clinical use remain contingent on individual healthcare provider preferences. Although novel legislation and policy continue to promote biosimilar drug development, clinician hesitancies curtail biosimilar use in practice, thereby limiting overall market uptake. Findings from a recently published systematic review indicate that clinicians in Europe and the US do not primarily support the use of biosimilars as safe and effective therapies in patients already receiving originator biological treatment [1].

Comparison of Brazilian regulations for follow-on biologicals with EMA, FDA and WHO

Biosimilars/Research | Posted 15/03/2019

Authors Marcos Renato de Assis and Valdair Pinto outline the strengths and weaknesses of the Brazilian regulation on follow-on biologicals and compare regulations in Europe, the US and the world [1].

Trastuzumab biosimilar PF 05280014 non-inferior to Herceptin

Biosimilars/Research | Posted 15/03/2019

Results of a study of Pfizer’s trastuzumab biosimilar (PF 05280014) have shown that the biosimilar is non-inferior to the originator biological, Roche’s Herceptin (trastuzumab) [1].

Positive phase I results for Mycenax’s tocilizumab biosimilar

Biosimilars/Research | Posted 08/03/2019

Taiwanese biosimilars developer Mycenax announced on 31 December 2018 that results from the phase I study of its tocilizumab biosimilar, LusiNEX, had met its primary endpoints.

Mandatory and non-mandatory switching for biosimilars

Biosimilars/Research | Posted 01/03/2019

Glintborg and co-authors responded to the comments made by Marc Scherlinger and Thierry Schaeverbeke on their paper ‘To switch or not to switch’, which reported the results of biosimilar etanercept switching in Denmark [1].

Positive phase III results for rituximab biosimilar CT-P10

Biosimilars/Research | Posted 25/01/2019

Celltrion has presented positive phase III results for its rituximab biosimilar CT‑P10 at the American Society of Hematology Meeting (ASH) annual meeting.

Biosimilar teriparatide approved for the treatment of osteoporosis

Biosimilars/Research | Posted 22/02/2019

Osteoporosis is a modern day epidemic longevity has brought about and represents an enormous socioeconomic burden. Being largely asymptomatic the silent thief can get away with insidiously stealing the patient’s bones until, as a result of the relentless bone loss, fragility fractures inevitably occur. The first, so-called sentinel fracture is the forerunner of the devastating fracture cascade as any prior fracture translates into a two- to four-fold increase in the risk of sustaining a subsequent one within one year [1].

Positive phase III results for rituximab biosimilar ABP 798

Biosimilars/Research | Posted 01/03/2019

Biotech giant Amgen, and its partner Allergan, announced on 24 January 2019 positive data from a phase I/III study of its rituximab biosimilar (ABP 798) compared to Rituxan (rituximab).

Questions over DANBIO relevance for non-medical switching

Biosimilars/Research | Posted 22/02/2019

Italian rheumatologists Fabrizio Cantini and Maurizio Benucci commented on the paper from Glintborg and co-authors ‘To switch or not to switch’, which reported the results of biosimilar etanercept switching in Denmark [1].

Long-term stability of trastuzumab biosimilar under various storage conditions

Biosimilars/Research | Posted 08/02/2019

Trastuzumab (TTZ) is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2). In some cancers, including certain types of breast cancers and gastric cancers, HER2 is overexpressed, causing cancer cells to reproduce uncontrollably. TTZ can be used in the management of these cancers.

Barriers and facilitators to biosimilar prescribing in the UK

Biosimilars/Research | Posted 08/02/2019

At present, the rate of uptake of biosimilars is keenly debated among stakeholders in different healthcare specialties. Aladul et al. examined the perspectives on biosimilars among healthcare professionals (HCPs) from gastroenterology, rheumatology and diabetes specialities to shed light on barriers and facilitators to their prescribing in the UK [1]. In a qualitative, cross-sectional study, 22 HCPs (consultants, nurses and pharmacists) from five hospitals in the West Midlands were interviewed.

Liability chain of biosimilar switching

Biosimilars/Research | Posted 01/02/2019

When an adverse event to a medicinal product, or a loss of efficacy, is experienced by a patient, the liability chain may potentially involve both the manufacturer and/or Marketing Authorization Holder (MAH) (products liability) and the healthcare professionals responsible for prescribing, dispensing and/or administrating (professional liability) the medicine.

Biosimilars - to switch or not to switch

Biosimilars/Research | Posted 25/01/2019

Authors Marc Scherlinger and Thierry Schaeverbeke commented on the paper from Glintborg and co-authors ‘To switch or not to switch’ ,which reported the results of biosimilar etanercept switching in Denmark [1].

EMA continues to be open to alternative clinical development strategies for biosimilars

Biosimilars/Research | Posted 18/01/2019

In the European Union (EU) and other highly regulated markets, companies need to prove the similarity of proposed biosimilars to the established reference product for gaining market authorization. European regulators recommend using a stepwise approach whose first steps consist of a demonstration of similarity at the analytical level and via non-clinical studies. In addition, as a later step, clinical studies are an important source of additional evidence.

Positive phase III results for rituximab biosimilar PF 05280586

Biosimilars/Research | Posted 18/01/2019

Pfizer has presented positive phase III results for its rituximab biosimilar PF‑05280586 at the American Society of Hematology Meeting (ASH) annual meeting.

Long-term follow-up of switching to biosimilar infliximab

Biosimilars/Research | Posted 11/01/2019

A study of long-term follow-up data after switching to biosimilar infliximab appears to show identical retention rates, according to French researchers [1].

Phase III study of biosimilar pegfilgrastim confirms safety and effectiveness in patients on myelosuppressive chemotherapy

Biosimilars/Research | Posted 09/11/2018

Canada-based Apobiologix, a division of Apotex, reported results of an international, phase III, randomized, double-blind clinical trial to demonstrate biosimilarity between the Apotex pegfilgrastim biosimilar (Apo-Peg; Lapelga) and reference product Neulasta (Amgen) [1].

Biosimilars in Europe

Biosimilars/Research | Posted 01/06/2018

The European Medicines Agency (EMA) has pioneered the regulatory aspects of biosimilars since the first approval of a biosimilar in 2006. With the last authorization of bevacizumab in January 2018, 44 biosimilar products have been reviewed by the Committee for Medicinal Products for Human Use (CHMP) of EMA, 41 of them having been granted a marketing authorization [1].

Safety of biosimilar infliximab in pregnant women with IBD

Biosimilars/Research | Posted 11/05/2018

Introduction of the first biosimilar infliximab (CT‑P13, Remsima/Inflectra) for the treatment of inflammatory bowel diseases (IBDs) was aimed to reduce the healthcare cost burden and to increase the number of treated individuals with similar treatment results. Shortly after CT‑P13 has been authorized for usage in clinical practice, many concerns arose due to the fact that the principle of extrapolation of limited clinical results had been applied to the biosimilar, which led to approval of the biosimilar in all the indications of the originator biological (Remicade). However, these concerns have proved to be unfounded, as subsequent studies have confirmed the similar efficacy, safety and immunogenicity of CT‑P13 and Remicade in the general IBD population [1].

European regulatory framework for approval of biosimilars – perspectives and future developments

Biosimilars/Research | Posted 15/02/2019

Regulatory agencies around the world have reviewed and approved marketing authorization applications for biosimilars via specific marketing authorization procedures that vary between jurisdictions. In Europe, the European Medicines Agency (EMA) has already more than 10 years of experience with review of applications and approval of biosimilars for use in the European Union.

Safety surveillance of bevacizumab biosimilar (Bevax) in Argentina

Biosimilars/Research | Posted 15/02/2019

Benefit-risk evaluations are mandatory throughout the life cycle of a therapeutic agent, to guarantee efficacy for the authorized indications without an unacceptable incidence of adverse effects. This monitoring can be carried out using pharmacovigilance (PhV) procedures, which are vital in the identification and prevention of adverse drug reactions (ADRs). Due to the inherent variability of bioproduction, this is of paramount importance for biological products, including biosimilars.

Positive results for adalimumab and etanercept biosimilars from Sandoz

Biosimilars/Research | Posted 14/12/2018

On 23 October 2018, Sandoz, the generics division of Novartis, presented positive phase III data for its adalimumab and etanercept biosimilars [1, 2].

Positive phase I results for Fresenius Kabi’s pegfilgrastim biosimilar

Biosimilars/Research | Posted 07/12/2018

Fresenius Kabi, one of the independently operated business segments of global healthcare group Fresenius, announced on 9 October 2018 that results from two phase I studies of its pegfilgrastim biosimilar (MSB11455) had met their primary endpoints.

Positive results for Chinese rituximab and trastuzumab copy biologicals

Biosimilars/Research | Posted 07/12/2018

Researchers from Shanghai Henlius Biotech have presented positive phase III study results for their rituximab [1] and trastuzumab [2] copy biologicals.

Bioequivalence of bevacizumab biosimilar (BEVZ92) versus Avastin in mCRC patients

Biosimilars/Research | Posted 28/09/2018

Researchers from mAbxience presented data that supports the pharmacokinetic (PK) bioequivalence between bevacizumab biosimilar BEVZ92 and originator bevacizumab (Avastin) as first-line treatment in combination with fluorouracil, leucovorin and oxaliplatin (FOLFOX) or fluorouracil, leucovorin, and irinotecan (FOLFIRI). in patients with metastatic colorectal cancer (mCRC) [1].

Switching from reference products to biosimilars: the European perspective

Biosimilars/Research | Posted 30/11/2018

The number of biosimilars receiving marketing authorization has grown steadily over the past several years [1, 2] and is expected to continue growing in the future. Particularly when biologicals are prescribed for the treatment of chronic diseases, switching patients from the originator biological to the biosimilar is increasingly becoming an option, allowing for a considerable reduction of public health expenditure. This article [3] provides an overview of current approaches in Europe to switching patients to treatment with biosimilars.

Comparative results for CT-P10 in low-tumour burden FL

Biosimilars/Research | Posted 30/11/2018

According to research in patients with low-tumour burden follicular lymphoma (FL), the efficacy and pharmacokinetics of rituximab biosimilar CT‑P10 are equivalent or non-inferior to the originator rituximab, Roche’s MabThera/Rituxan [1].

Safety of originator and biosimilar epoetin alfa drugs

Biosimilars/Research | Posted 23/11/2018

Researchers from Italy carried out a study to compare the safety profile of biosimilars with respect to the reference product in a nephrology setting. The results confirm the comparable safety profiles of originator and biosimilar epoetin alfa drugs when used in patients receiving dialysis [1].

Positive phase III data for adalimumab biosimilar Cyltezo

Biosimilars/Research | Posted 23/11/2018

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) announced on 12 September 2018 positive phase III data for its adalimumab biosimilar, Cyltezo [1]. The results, according to Boehringer Ingelheim ‘confirm that Cyltezo is equivalent to Humira, with no clinically meaningful differences in efficacy safety and immunogenicity in people with moderate-to-severe chronic plaque psoriasis’.

Phase I study suggests similarity of omalizumab biosimilar

Biosimilars/Research | Posted 16/11/2018

Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 25 July 2018 that results from a phase I study suggest similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles between Glenmark’s proposed omalizumab biosimilar GBR 310 and the originator product Xolair (omalizumab).

Inflectra may not be less expensive than Remicade in US

Biosimilars/Research | Posted 09/11/2018

According to research carried out in the US, the cost of the infliximab biosimilar Inflectra (infliximab-dyyb) was only moderately less expensive than the originator biological Remicade (infliximab) in treating rheumatoid arthritis (RA) and exceeded US$14,000 annually under Medicare^# Part D*. In addition, out-of-pocket costs for patients taking Inflectra may be more than US$1,700 higher than for patients taking Remicade.

Real-life clinical effectiveness of Razumab in retinal vein occlusion

Biosimilars/Research | Posted 02/11/2018

Authors from Intas Pharmaceuticals presented data from a subgroup analysis of the RE-ENACT study (retrospective, multicentre, observational pooled study on wet age-related macular degeneration [wet AMD], diabetic macular oedema, and retinal vein occlusion) [1]. The RE-ENACT study evaluated the effectiveness of the ranibizumab similar biologic Razumab in Indian patients with retinal vein occlusion (RVO).

Clinical and real-world data for switching to biosimilars

Biosimilars/Research | Posted 02/11/2018

The evidence and issues associated with switching from originator biological disease-modifying antirheumatic drugs (DMARDs) to biosimilars are discussed by authors from French universities and hospitals [1].

Mass spectrometry comparison of Remicade and Remsima

Biosimilars/Research | Posted 26/10/2018

The US entered the era of biosimilars in 2015 with its very first US Food and Drug Administration (FDA) approved filgrastim biosimilar Zarxio (filgrastim-sndz) [1]. Since then, FDA has approved 11 more biosimilars [2]. Nevertheless, one concern with respect to the manufacturing of biosimilars is that every company has its own proprietary manufacturing process, which could potentially lead to differences in drug properties. Consequently, the debate on how ‘similar’ the biosimilar is to the originator still remains controversial. Thus, a comprehensive but rapid characterization platform that can validate any clinically meaningful differences is required. In this regard, Pisupati et al. [3] carried out a study comparing the reference product Remicade (infliximab) with the first US monoclonal antibody (mAb) biosimilar Remsima (Europe)/Inflectra (US) by incorporating state-of-the-art mass spectrometry-based multiple-attribute monitoring (MAM).

Switching to etanercept biosimilar SB4 safe and effective in a hospital setting

Biosimilars/Research | Posted 26/10/2018

Authors of a study carried out at a UK hospital found switching to etanercept biosimilar SB4 to be safe and effective [1].

Expediting FDA approvals for biosimilars

Biosimilars/Research | Posted 19/10/2018

A number of recommendations for the US Food and Drug Administration (FDA) to simplify biosimilar licensing laws, and thus make biosimilars more accessible, are offered in a recent review [1]. Recommendations include allowing smaller batch sizes for testing, encouraging substitution for naïve patients, and removing the requirement for bridging studies.

Phase III trial for subcutaneous Remsima completed

Biosimilars/Research | Posted 19/10/2018

Celltrion Healthcare (Celltrion) announced on 29 August 2018 that it had completed a phase III study with the subcutaneous (SC) version of its infliximab biosimilar Remsima (CT‑P13).

Reasons for switching to biosimilars and immunogenicity

Biosimilars/Research | Posted 12/10/2018

Authors from French universities and hospitals discussed the evidence and issues associated with switching from originator biological to biosimilars [1].

Stakeholder perspectives on biosimilars in oncology

Biosimilars/Research | Posted 05/10/2018

Monoclonal antibody biosimilars represent a novel advance in the field of oncology, and their integration into routine clinical practice present challenges for clinicians, nurses, patients and regulators. Researchers therefore investigated the perspectives stakeholders including a clinician, specialist nurse, patient advocate, regulator and economist on optimizing the uptake of monoclonal antibody biosimilars in the treatment of cancer [1].

Pharmacokinetics of CT-P6 in patients with HER2+ early-stage breast cancer

Biosimilars/Research | Posted 05/10/2018

Researchers from Celltrion presented data that support the pharmacokinetic (PK) similarity between trastuzumab biosimilar CT‑P6 and originator trastuzumab (Herceptin) [1].

Recommendations for biosimilars in rheumatology in the Middle East

Biosimilars/Research | Posted 28/09/2018

The increasing availability of biosimilars in Middle Eastern regions may provide an opportunity to increase the number of rheumatology patients who have access to traditionally more expensive biologicals. However, as well as a lack of real-world data on the use of biosimilars in practice, the availability of ‘intended copies*’ in the region may undermine physician confidence in prescribing legitimate biosimilars. There is a need for regional recommendations for healthcare professionals to ensure that biosimilars can be used safely.

Selection of quality attributes and test methods in biosimilarity assessment

Biosimilars/Research | Posted 21/09/2018

Biosimilar development starts with a detailed characterization of the quality profile of the chosen reference product, to establish targets for cell line and process development, according to author Vandekerckhove and colleagues [1]. This characterization requires a careful determination of the range of variability for all relevant product quality attributes of the reference product, as well as an understanding of their relative importance, to ensure appropriate focus on the most important attributes. Following process development, similarity of the biosimilar candidate with the reference product must be demonstrated in comprehensive analytical studies. This first step in the demonstration of biosimilarity provides the most sensitive measurement of differences; and is instrumental in deciding the direction of further product development. Meticulous design of the analytical similarity programme is therefore critical to the success of biosimilar development.

Increase in use of biosimilar rituximab for NHL treatment

Biosimilars/Research | Posted 21/09/2018

Researchers from the UK and US reported on how the treatment approach for non-Hodgkin lymphoma (NHL) patients has changed since the first biosimilars of rituximab were approved in the European Union five (EU5: France, Germany, Italy, Spain, UK) [1].

Comparison of biosimilar and originator bevacizumab in NSCLC

Biosimilars/Research | Posted 14/09/2018

A study carried out by international researchers reported results from a comparative clinical study of PF‑06439535, a candidate bevacizumab biosimilar compared to originator bevacizumab, in patients with advanced non-squamous non-small cell lung cancer (NSCLC) [1].

Pooled analysis results of adalimumab, etanercept and infliximab biosimilars

Biosimilars/Research | Posted 07/09/2018

South Korean electronics giant Samsung and biotechnology company Biogen Idec (Biogen) joint venture Samsung Bioepis, along with Biogen, announced on 13 June 2018 results of a pooled analysis combining data from three phase III trials that compared the efficacy and safety of anti-tumour necrosis factor (anti-TNF) biosimilars to their reference biologicals.

Comparison of trial and real-world data for biosimilar filgrastim

Biosimilars/Research | Posted 07/09/2018

A study carried out by researchers from Germany compared results from a randomized controlled trial (RCT) of Sandoz’s biosimilar filgrastim and post-approval data on the safety of the biosimilar [1].

Alternative mAb purification strategies: a tool to increase global access to biotherapeutics?

Biosimilars/Research | Posted 31/08/2018

The monoclonal antibodies’ (mAbs) market is dominant among therapeutic biologicals. Between 2013 and 2017, it has witnessed the approval of 11 biosimilars and 33 new molecules by the regulatory authorities in the EU and the US [1]. A foreseen increase in demand arising from both the western world and several developing countries requires a productivity increase at the same time that the biopharmaceutical industry is being pressured to reduce the costs of life-saving drugs.

Positive switching data for infliximab and etanercept biosimilars

Biosimilars/Research | Posted 31/08/2018

Sandoz, the generics division of Novartis, announced on 15 June 2018 results of new phase III, long-term and switching data for its infliximab biosimilar Zessly (PF‑06438179) and its etanercept biosimilar Erelzi in rheumatoid arthritis patients.

Switching from Basalin to Lantus effective in Chinese diabetes patients

Biosimilars/Research | Posted 24/08/2018

Switching from copy biological (Basalin) to originator (Lantus) insulin glargine is effective in Chinese patients with diabetes mellitus, according to authors from the Qingdao Endocrine and Diabetes Hospital, China [1].

Safety and immunogenicity of originator and biosimilar trastuzumab

Biosimilars/Research | Posted 24/08/2018

A study carried out by international researchers reported results from the HERiTAge trial of Mylan/Biocon’s biosimilar trastuzumab, Ogivri (trastuzumab‑dkst) [1].

Positive phase III results for Amgen’s infliximab biosimilar

Biosimilars/Research | Posted 20/07/2018

Biotech giant Amgen announced on 27 June 2018 positive data from a phase III study of their infliximab biosimilar (ABP 710) compared to Remicade (infliximab).

Biosimilars: implications for oncologists

Biosimilars/Research | Posted 13/07/2018

In 2015, the US Food and Drug Administration (FDA) approved its first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since then, FDA has approved four additional biosimilar tumour necrosis factor α inhibitors, and in May 2017, the Oncology Drug Advisory Committee voted in favour of approval of an epoetin alfa biosimilar. Three biosimilar monoclonal antibodies (mAbs) have been approved in the US. Although their indications are for chronic inflammatory diseases, according to authors Robert Rifkin and Susan Peck, oncologists should become familiar with these agents, because they may need to administer these drugs for patients who have concurrent chronic inflammatory conditions [1].

Positive results for infliximab and trastuzumab biosimilars

Biosimilars/Research | Posted 13/07/2018

Celltrion Healthcare (Celltrion) and Samsung Bioepis have both announced positive results for their infliximab and trastuzumab biosimilars, respectively.

Biosimilarity testing using very low doses of rituximab

Biosimilars/Research | Posted 06/07/2018

Rituximab is a chimeric, monoclonal antibody directed against CD20 expressed on B lymphocytes [1]. Currently approved indications for use are non-Hodgkin lymphomas, chronic lymphatic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic angiitis [2]. However, rituximab is frequently used ‘off label’ for the treatment of numerous antibody-dependent autoimmune diseases [3].

Scientific rationale for extrapolation of cancer indications

Biosimilars/Research | Posted 07/07/2017

Extrapolation involves extending and applying the data from clinical studies regarding one medical condition to another medical condition. Once biosimilarity has been proven, biosimilars can also be approved for one or more additional indications held by the reference product, without the need for clinical data in those indications. Author Michinori Ogura from the Tokai Central Hospital, Gifu, Japan and colleagues from France and South Korea investigated the scientific rationale for extrapolation using the rituximab biosimilar CT-P10 as an example [1].

Biosimilar insulins have same efficacy and safety as reference biologicals

Biosimilars/Research | Posted 29/06/2018

Researchers from the US have found that biosimilar insulins have comparable safety and clinical efficacy as their reference biologicals [1].

Savings with use of biosimilar trastuzumab for breast cancer patients in Croatia

Biosimilars/Research | Posted 29/06/2018

Breast cancer is worldwide the most common cancer in women. In 2012 alone, there were approximately 464,000 new cases and 131,000 deaths from breast cancer in Europe. In Croatia, breast cancer was the fourth leading cause of death among women and ninth in both sexes in 2016.

Biosimilars and the role of regulatory authorities

Biosimilars/Research | Posted 22/06/2018

According to authors Hye-Na Kang and Ivana Knezevic, from the World Health Organization (WHO), market access to biosimilars can be restricted by several factors [1]:
(i) manufacturing processes may be expensive and complex
(ii) patents on the manufacturing processes of the original product may not have expired
(iii) biosimilar manufacturers may have limited access to data on the original product
(iv) appropriate regulatory frameworks may not be in place
(v) government policies on switching to biosimilars, pricing and reimbursement may be lacking.

Life cycle and regulatory evaluation of biosimilars

Biosimilars/Research | Posted 15/06/2018

The life cycle of a biosimilar, like any biological, starts with research and development, then manufacturing, and is followed by regulatory evaluation of quality, safety and efficacy for both licensing and post-licensing oversight. Once licensed, a biosimilar is an individual product and post-licensing evaluation should be carried out like any other biological. The only difference for a biosimilar is that regulatory approval relies on the safety and efficacy data and knowledge gained during the development and licensing of an originator, or reference product.

Regulating biosimilars throughout their life cycle

Biosimilars/Research | Posted 08/06/2018

A resolution to increase access to life-saving biologicals was passed in May 2014 at the Sixty-seventh World Health Assembly of the World Health Organization (WHO) [1]. However, there still exist barriers to market access for biosimilars. Authors Drs Hye-Na Kang and Ivana Knezevic, from WHO, discuss the factors that give rise to these barriers and explain the importance of regulatory oversight throughout the product life-cycle of biosimilars [2].

Interchangeability between infliximab biosimilars with respect to immunogenicity

Biosimilars/Research | Posted 01/06/2018

In their editorial, Katsanos and colleagues [1] discuss a study carried out by Italian and Spanish researchers on the immunogenicity of infliximab biosimilars that finds that there is full interchangeability between infliximab biosimilars with respect to immunogenicity [2].

Utilization data and cost-effectiveness of infliximab biosimilar

Biosimilars/Research | Posted 25/05/2018

Studies of Celltrion/Hospira’s infliximab biosimilar (CT‑P13, Remsima/Inflectra) carried out in Canada and Germany have shown that, although there are large savings to be made, there are ‘significant differences in real-world utilization patterns’ of patients prescribed originator infliximab compared to those prescribed biosimilar infliximab (CT‑P13) [1, 2].

Secrecy is an obstacle to the use of biosimilars in the US

Biosimilars/Research | Posted 11/05/2018

Factors that Professor Frank believes may be affecting uptake include naming and interchangeability guidance, insurance payment arrangements and secrecy about manufacturing processes [1]. In this article, secrecy about manufacturing processes is discussed.

Insurance payment arrangements are an obstacle to biosimilars use in the US

Biosimilars/Research | Posted 04/05/2018

The slow development of the market competition for biosimilars in the US may be caused by several factors, according to Professor Richard Frank from the Department of Health Care Policy, Harvard Medical School, Boston, USA [1]. In this article, insurance payment arrangements for biologicals and biosimilars are discussed.

Biosimilars in rheumatology: the current state of play

Biosimilars/Research | Posted 04/05/2018

Biological disease modifying anti-rheumatic drugs (bDMARDs) have revolutionized the management of rheumatoid arthritis (RA) and other inflammatory diseases. Over two decades, their use has risen exponentially but their significant cost has contributed to increasing healthcare expenditure in many countries. Biosimilar development is an opportunity to lower drug expenses and optimize use. This review detailed the current state of biosimilars in rheumatology, including their development, trial data, economic impact and logistical considerations [1].

Interchangeability is an obstacle to the use of biosimilars in the US

Biosimilars/Research | Posted 27/04/2018

According to Professor Richard Frank from the Department of Health Care Policy, Harvard Medical School, Boston, USA, there are several factors that may account for the slow development of the market for biosimilars in the US [1]. In this article, the issue of interchangeability of biosimilars is discussed.

Phase I study of biosimilar trastuzumab demonstrates equivalent pharmacokinetics to reference product

Biosimilars/Research | Posted 27/04/2018

Trastuzumab, a recombinant humanized monoclonal antibody, acts against the tyrosine kinase human epidermal growth factor receptor 2 (HER2), which is overexpressed in up to 30% of breast cancers and gastric cancers and has been linked to poor prognosis. In the age of targeted anticancer therapy, trastuzumab is a key treatment for patients with HER2-positive (HER2+) tumours and is recommended by a number of clinical guidelines. However, the use of ‘originator’ (or reference) biologicals, such as trastuzumab, is associated with high treatment costs; an issue set to be exacerbated by an ageing population. The improved cost-effectiveness potentially provided by a biosimilar may increase patient access to treatment.

Afucosylated biosimilars: the path to matching interrelated critical quality attributes

Biosimilars/Research | Posted 20/04/2018

Advances in analytical characterization and increased understanding of drug mechanisms of action have resulted in the ability to raise the quality and safety of biosimilars by introducing critical quality attributes (CQA), which must be preserved during the manufacturing process. However, to realize these benefits, biosimilars manufacturers must develop the means to ensure these CQAs are met. For afucosylated IgG1s that rely on afucosylation content for efficacy, this has been challenging, since precisely matching both afucosylation content and biological activity has proven to be extremely difficult. In a recent paper, Chung and Zhan [1] elaborate on the underlying basis of these difficulties and highlight the work of several groups that has opened a path to directly addressing this problem.

Naming is an obstacle to the use of biosimilars in the US

Biosimilars/Research | Posted 20/04/2018

Factors that may account for the slow development of the market for biosimilars in the US are discussed by Professor Richard Frank from the Department of Health Care Policy, Harvard Medical School, Boston, USA [1]. In this article, the factor of biosimilars naming is discussed.

Obstacles to the use of biosimilars in the US

Biosimilars/Research | Posted 13/04/2018

Professor Richard G Frank from the Department of Health Care Policy, Harvard Medical School, Boston, USA, discusses factors that may account for the slow development of competition in the market for biosimilars in the US [1].

Strategies for development and validation of neutralizing antibody assays supporting biosimilars

Biosimilars/Research | Posted 13/04/2018

A biosimilar is a biological product with equivalent safety, purity and potency as an originator reference therapeutic. As such, US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidelines have stepwise recommendations to demonstrate biosimilarity, which include immunogenicity assessment.

Biosimilar policies in Europe

Biosimilars/Research | Posted 06/04/2018

Across European countries, differences exist in biosimilar policies, e.g. pricing and reimbursement procedures, levels of education, characteristics of covered population and incentivization of stakeholders, leading to variations in uptake of biosimilars and divergences in savings from biosimilars use. Experiences from different European countries with biosimilar policies may offer useful insights into current and future uptake of biosimilars.

Etanercept biosimilar SB4 less immunogenic than Enbrel

Biosimilars/Research | Posted 06/04/2018

A research letter published in the British Journal of Dermatology suggests that the biosimilar etanercept SB4 is less immunogenic than the originator product, Amgen/Pfizer’s Enbrel (etanercept) [1].

Government policies to maximize social benefit of biosimilars in countries with restricted access to biologicals

Biosimilars/Research | Posted 30/03/2018

The potential value of biosimilars is dependent on patient access to originator biologicals in a given country. If the originator biological is reimbursed without any volume and access restrictions, the main objective of using biosimilars is to generate savings in health expenditures without compromising health outcomes. This disinvestment scenario is mainly applicable for higher income countries. If the original biological product is reimbursed with volume and access restrictions, the main objective of biosimilars is to treat more patients from the same healthcare budget, and hence generate more health gain. This special investment scenario is applicable for lower income European Union (EU) Member States and other middle-income countries. If the originator biological is not reimbursed at all, more affordable biosimilars may create an opportunity for public reimbursement, however, incremental budget is needed to generate more health gain. This investment scenario is applicable for low-income countries [1].

Yoshindo and Lupin’s etanercept biosimilar completes trials

Biosimilars/Research | Posted 23/03/2018

YL Biologics announced on 7 February 2018 that the global phase III trials of its etanercept biosimilar have been a success. YL Biologics is a joint venture of India’s Lupin Ltd and Japanese firm Yoshindo that was first announced in 2014 [1]. The etanercept biosimilar has met a successful outcome for rheumatoid arthritis treatment and hopes to compete for a share of the originator Enbrel’s global market of US$11 billion.

PK and PD comparison between rituximab biosimilar RTXM83 and rituximab in diffuse large B-cell lymphoma patients

Biosimilars/Research | Posted 23/03/2018

A requirement for registration of a biosimilar is to demonstrate pharmacokinetic (PK) similarity with the reference product. A population PK model approach is an excellent method for assessing PK similarity, in contrast to the classical one, because it allows comparison of PK properties through the inclusion of sparse data that improves the power to detect any potential differences between the biosimilar and the reference product. Furthermore, the population approach allows quantification of the inter-product and inter-subject variability of PK parameters and identification of covariate factors (demographic, pathophysiological, environmental or concomitant drugs) that influence drug availability [1].

Follow-on biologicals and extrapolation in Brazil

Biosimilars/Research | Posted 16/03/2018

Researchers from Brazil discuss the country’s approach to follow-on biologicals and extrapolation of indications in the country [1].

Biosimilar policies around the globe

Biosimilars/Research | Posted 16/03/2018

With the authorization of an increasing number of biosimilars, and the prospect of multiple biosimilar switching, biosimilar naming and the importance of this for pharmacovigilance are coming into sharper focus. Authors from around the world considered various biosimilar issues/policies in different countries and regions [1].

Use and cost of biologicals for cancer treatment in Southern Italy

Biosimilars/Research | Posted 09/03/2018

Oncological-targeted therapies, both biological and non-biological, represent a significant clinical and economic burden in routine care and have a major impact on the sustainability of National Health Services. With this in mind, a study by Lucchesi et al. investigated the use and costs of these targeted therapies for cancer treatment in the general population of Southern Italy during the period 2010−2014 [1].

Structure-function relationship between disulfide bonds and TNF-α neutralization in etanercept

Biosimilars/Research | Posted 09/02/2018

Research carried out by Sandoz describes how a novel incorrect disulfide bridge structure present at low levels in commercial etanercept inhibits etanercept potency by reducing its ability to neutralize soluble tumour necrosis factor alpha (TNF-α) [1].

Pharmacy-mediated substitution: the global policy landscape

Biosimilars/Research | Posted 02/03/2018

There is a complex global regulatory landscape when it comes to biosimilars. In particular, there is much debate over substitution practices. Substitution describes the practice where a pharmacist decides to change a product, dispensing an equivalent (generic small molecule) or highly similar product (biosimilar) without the prescribing physician’s prior consent. This is distinct from switching, whereby a physician changes a patient’s treatment, between reference product and a biosimilar, or between biosimilars. Between March and May 2017, Pfizer conducted an internal global survey of 82 countries in which it examined biosimilar pharmacy-mediated substitution. Here, the company hoped to understand and benchmark the global policy landscape [1].

Kissei/JCR’s darbepoetin alfa biosimilar shows equivalent safety and efficacy

Biosimilars/Research | Posted 02/03/2018

Japan-based collaborators Kissei Pharmaceutical (Kissei) and JCR Pharmaceuticals (JCR) announced on 17 January 2018 positive results for the phase III study of their candidate darbepoetin alfa biosimilar, JR‑131.

Strategies of players on the global biopharmaceutical market

Biosimilars/Research | Posted 08/09/2017

With many expensive and high-selling biologicals losing patent protection and other exclusivity rights, biosimilars of these molecules may now enter the market, resulting in a shift of market shares, revision of strategies of companies and attraction of new players to the biopharmaceutical market.

Barriers to the market access of biosimilar monoclonal antibodies

Biosimilars/Research | Posted 25/08/2017

In September 2013, the first biosimilar monoclonal antibody (mAb) was approved by the European Medicines Agency (EMA), i.e. biosimilar infliximab (Inflectra/Remsima). These products entered the European market in 2015, after expiry of patent and other exclusivity rights of the innovator medicine Remicade. With the ever-increasing cost of health care and the economic pressure to reduce or sustain healthcare expenses, biosimilars could be instrumental in reducing cost for medication and increasing patient access to treatment. Although exclusivity rights of multiple mAbs are expired (rituximab in 2013, trastuzumab in 2014), only recently biosimilar mAbs other than infliximab are receiving marketing authorization (rituximab, adalimumab). Furthermore, earlier biosimilars have seen slow uptake in European markets. This may imply that several barriers hinder market access of biosimilar mAbs.

Generics versus biosimilars: pricing and usage-enhancing policies

Biosimilars/Research | Posted 23/02/2018

In Europe, pricing and demand-side measures for generic medicines are widely implemented and have undergone evaluations [1-4]. However, when it comes to biosimilars, the policies implemented by European countries are less well known and explored.

Etanercept switching study investigates non-mandatory transitioning

Biosimilars/Research | Posted 23/02/2018

A study carried out by researchers from The Netherlands investigated whether non-mandatory transitioning from originator to biosimilar etanercept improves retention rates [1].

EBE reveals Europe’s biosimilar pricing and reimbursement policies landscape

Biosimilars/Research | Posted 15/02/2018

The first biosimilar was approved in the European Union (EU) in 2006. Since then, biosimilar policies have been developed with a focus on increasing biosimilar uptake. However, the extent to which EU Member State polices differentiate between biosimilars and generic medicines has been brought into question. The European Biopharmaceutical Enterprises (EBE) has conducted a second survey on pricing and reimbursement policies for off-patent biologicals to map the biosimilar policy landscape in Europe [1].

Quality and clinical performance of biopharmaceuticals

Biosimilars/Research | Posted 15/02/2018

A review carried out by researchers from Sandoz describes the inherent nature of biopharmaceutical heterogeneity and discusses modern quality systems and regulatory frameworks used to maintain biopharmaceutical quality and clinical performance [1].

Zarxio reveals all: the US biosimilars market

Biosimilars/Research | Posted 09/02/2018

Launched in 2015, Zarxio (filgrastim-sndz) was the first biosimilar to gain US Food and Drug Administration (FDA) approval [1]. It competes with Neupogen (its reference product), Granix and Neulasta, for a share of the neutropenia market. This approval came almost a decade after the 2006 launch of the first biosimilar in Europe. Following this, a new study has examined Zarxio’s first years’ performance in the US short-acting (SA) filgrastim market to identify key sales and marketing trends and their drivers [2].

The biosimilar landscape in Italy revealed

Biosimilars/Research | Posted 02/02/2018

In Italy, health services are run at the regional level. To date, there has been no systematic monitoring of the uptake of biosimilars at a national or regional level. As such, the biosimilar landscape in Italy has not been well understood. However, a recent paper now provides an overview of the available real-world data relating to the patterns of use and the comparative effectiveness of biosimilars and originator biological drugs in Italy [1].

Danish etanercept switching study investigates withdrawal rates

Biosimilars/Research | Posted 02/02/2018

A study carried out by researchers from Denmark has investigated switching from originator to biosimilar etanercept 1-year post switch [1].

Switching to biosimilars in rheumatology

Biosimilars/Research | Posted 26/01/2018

Researchers from Argentina, Brazil, Germany, the UK and the US investigated switching from originator biologicals to biosimilars [1].

Additional clinical data for Cinfa’s pegfilgrastim biosimilar

Biosimilars/Research | Posted 19/01/2018

Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 2 November 2017 additional clinical data for its candidate pegfilgrastim biosimilar (B12019).

Switching failures with biosimilar etanercept

Biosimilars/Research | Posted 12/01/2018

A study carried out by researchers from Denmark has found that switching from originator to biosimilar etanercept does not work for all patients [1].

Reimbursement for oncology biosimilars in the US

Biosimilars/Research | Posted 05/01/2018

How reimbursement issues for biosimilars might affect US oncologists was a subject discussed by Dr Rena Conti, Associate Professor of Health Policy and Economics in the Department of Paediatrics at the University of Chicago, USA [1].

Impact of follow-on biological products in the Brazilian health system

Biosimilars/Research | Posted 05/01/2018

Cancer is an epidemic disease in the 21st century. However, despite consistent increases on its incidence worldwide, mortality rates have fallen, especially in developed countries [1, 2]. The victories mankind has achieved in the war against cancer result from advances in different fields, such as early diagnosis and better surgical, radiotherapeutic and systemic treatments.

Hospital specialists and pharmacists surveyed about biosimilars

Biosimilars/Research | Posted 08/12/2017

Biological medicines are essential for many acute and chronic conditions, but their consumption differs widely among European countries [1, 2]. In contrast with the procedures for their approval[3], position papers from scientific societies suggest that biosimilars need to be tested in well-designed, randomized, controlled clinical trials, especially for extrapolation of indications [4, 5]. Nevertheless, switches with originators are becoming common and no serious adverse effects have been reported to date [6-8].

Positive phase III switching results for Celltrion’s infliximab biosimilar

Biosimilars/Research | Posted 08/12/2017

Results of a phase III extension study have shown that Celltrion Healthcare’s (Celltrion) infliximab biosimilar (CT-P13) is shown to be comparable in efficacy and safety to Johnson & Johnson/Merck’s Remicade in switched inflammatory bowel disease patients, according to the South Korean biotechnology company.

Switching from reference infliximab to CT P13 in IBD patients

Biosimilars/Research | Posted 01/12/2017

Argüelles-Arias and colleagues from the Hospital Universitario Virgen Macarena and the University of Seville in Spain carried out an observational study assessing the efficacy and safety of switching from Remicade to CT P13 in patients with inflammatory bowel disease (IBD) for up to 12 months [1].

Switching to biosimilar infliximab in IBD patients

Biosimilars/Research | Posted 24/11/2017

Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options, such as CT‑P13 (Remsima/Inflectra), promises to improve the availability of biological therapy.

Biosimilars in oncology in the US

Biosimilars/Research | Posted 24/11/2017

As part of the Affordable Care Act of 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) allows for an abbreviated license pathway for the approval of biosimilars in the US. In light of continuing increases in healthcare costs, particularly for cancer drugs, use of biosimilars is increasingly being considered as a strategy for containing the cost of cancer care, according to Dr Gary Lyman of the Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA, USA [1, 2].

Loss of efficacy after switching to biosimilar infliximab in Behcet’s patients

Biosimilars/Research | Posted 17/11/2017

Authors from the Division of Rheumatology at the Hospital of Prato, Italy report on three patients with Behçet’s disease that experienced disease relapses after switching from the originator infliximab, Remicade, to biosimilar infliximab [1].

Opportunities and challenges for biosimilars in oncology

Biosimilars/Research | Posted 17/11/2017

The rapid increase in healthcare costs, particularly for cancer drugs, has had a major impact on providers, practices, payers and patients, according to Dr Gary Lyman of the Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA, USA [1, 2].

Phase III switching data support long-term efficacy and safety of rituximab biosimilar Truxima

Biosimilars/Research | Posted 10/11/2017

Results of a phase III extension study have shown that Celltrion Healthcare’s (Celltrion) rituximab biosimilar (Truxima, CT-P10) is comparable to Roche’s MabThera/Rituxan, according to the South Korean biotechnology company.

Physicochemical and biological characterization study of copy biological tocilizumab

Biosimilars/Research | Posted 10/11/2017

Researchers in China have developed a copy biological of F. Hoffmann-La Roche’s (Roche) arthritis treatment Actemra (tocilizumab). A recent study compares it to the originator, finding it to be highly similar in terms of its physical, chemical and biological characteristics [1].

Australian prescribers’ views on biologicals naming and substitution

Biosimilars/Research | Posted 03/11/2017

In a survey of 160 prescribers of biologicals in Australia, over three quarters agreed that the country’s Therapeutic Goods Administration (TGA) should insist on distinct non-proprietary scientific names for all biosimilars and reference products. The results of the survey were published just as TGA launched a public consultation on proposals for potential biological naming systems. A clear majority (98%) of prescribers who took part in the survey, run by the Alliance for Safe Biologic Medicines (ASBM), said they currently used either brand name or non-proprietary scientific names for recording and prescribing biosimilars and reference products [1]. Most (61%) wanted TGA to play a major role in naming biosimilars.

Biosimilar insulins – reducing the cost of diabetes

Biosimilars/Research | Posted 03/11/2017

Will biosimilar insulins be cheaper is a question raised by authors Lutz Heinemann and Alan Carter and one that they say is a clear yes [1].

European perspective on biosimilars

Biosimilars/Research | Posted 27/10/2017

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. The first biosimilar Omnitrope (somatropin) was approved in 2006 [1].

Anti-drug antibody assays for biosimilars and originator biologicals

Biosimilars/Research | Posted 27/10/2017

Biosimilar drug development has brought new challenges to bioanalytical ligand-binding assays used to determine drug concentration, anti-drug antibodies and neutralizing antibodies.

Challenges and opportunities in producing biosimilars

Biosimilars/Research | Posted 20/10/2017

In a viewpoint article published in ACS Medicinal Chemistry Letters [1], Dahodwala and Sharfstein discuss the challenges and opportunities faced by biopharmaceutical manufacturers in producing biosimilars, equivalent versions of therapeutic proteins, and the role of regulatory agencies, particularly the US Food and Drug Administration (FDA), in approving these compounds.

Bevacizumab improves survival in NSCLC patients

Biosimilars/Research | Posted 20/10/2017

In what could be good news for recently approved bevacizumab biosimilar Mvasi, a study has shown that bevacizumab-containing regimens improve survival in advanced non-squamous non–small cell lung cancer (NSCLC) patients.

Adalimumab biosimilar ABP 501 shows similar efficacy, safety and immunogenicity

Biosimilars/Research | Posted 13/10/2017

Biosimilars are defined by the US Food and Drug Administration (FDA) as a biological product that is ‘highly similar to’ an approved biological product (the ‘reference’ or ‘originator’ or ‘bio-originator’ product) and that has ‘no clinically meaningful differences’ in safety or effectiveness compared to the reference product.

Barriers to access to biosimilars

Biosimilars/Research | Posted 13/10/2017

Barriers to the use of biosimilars include healthcare professional and patient opinions. But national and local guidelines, levels of funding and differing approaches to healthcare management can also influence access to biosimilars in different Member States of the European Union (EU), according to authors from the National Advisory Unit on Rehabilitation in Rheumatology and the Rheumatology Department of Diakonhjemmet Hospital, Oslo, Norway [1].

Integrating biosimilars into clinical practice

Biosimilars/Research | Posted 06/10/2017

According to authors from the National Advisory Unit on Rehabilitation in Rheumatology and the Rheumatology Department of Diakonhjemmet Hospital, Oslo, Norway, key questions when it comes to biosimilars include interchangeability, switching and automatic substitution [1].

Biosimilars for rheumatic diseases

Biosimilars/Research | Posted 29/09/2017

Biologicals have become central to the long-term management of many chronic diseases, including inflammatory rheumatic diseases. Biosimilars may help to fill an unmet need by improving patient access to effective biological treatments for chronic diseases. In light of these facts, authors from Norway reviewed biosimilars for rheumatic diseases [1].

Equivalence of rituximab biosimilar in rheumatoid arthritis

Biosimilars/Research | Posted 29/09/2017

A network meta-analysis was used by researchers from Italy to ‘reinforce the clinical data available’ for the equivalence of the rituximab biosimilar CT‑P10 [1].

Positive phase III results for Pfizer’s trastuzumab biosimilar

Biosimilars/Research | Posted 22/09/2017

Pharma giant Pfizer announced on 10 September 2017 positive results from the pivotal phase III study of its candidate trastuzumab biosimilar. Pfizer says that ‘data from the REFLECTIONS B327-02 study demonstrates equivalence in objective response rate (ORR) for patients with HER2-positive metastatic breast cancer’.

Comparable efficacy and safety observed in patients switched to biosimilar CT-P10

Biosimilars/Research | Posted 22/09/2017

Rituximab is a monoclonal antibody that targets the CD20 protein that is primarily found on B lymphocytes. Through depletion of CD20-positive B cells in the peripheral blood and bone marrow, rituximab is effective for treating some haematological malignancies and immune-mediated diseases such as rheumatoid arthritis (RA). CT-P10 (Truxima) is a biosimilar of the rituximab reference product. It is the first biosimilar to receive market authorization from the European Medicines Agency and is approved in Europe for all indications for which RTX is licensed [1]. A phase I randomized controlled trial (RCT) in patients with RA demonstrated pharmacokinetic equivalence of CT-P10 and reference rituximab over 24 weeks of treatment [2], and comparable efficacy and safety of these two drugs has recently been demonstrated over an extended treatment duration from the same trial [3]. With biosimilars typically being less expensive than originator biologicals [4], it is of interest to know whether patients treated with an originator biological can be switched to a biosimilar to save healthcare costs and increase access without affecting treatment efficacy or safety. An open-label extension (OLE) study that enrolled patients who had completed the aforementioned phase I RCT has been published [5]. The study has demonstrated comparable efficacy and safety profiles in patients who switched from the reference rituximab to CT-P10 and those maintained on CT-P10 throughout treatment [5].

Positive phase III results for Amgen’s trastuzumab biosimilar

Biosimilars/Research | Posted 15/09/2017

Biotech giant Amgen and partner Allergan announced on 9 September 2017 positive data from a phase III study of their trastuzumab biosimilar (ABP 980) compared to Herceptin (trastuzumab).

Positive phase I results for rituximab biosimilar CT-P10 in patients with rheumatoid arthritis

Biosimilars/Research | Posted 15/09/2017

Rituximab is an established anti-CD20 monoclonal antibody used for the treatment of some haematological cancers and immune-mediated diseases, such as rheumatoid arthritis (RA). CT-P10 (Truxima) is the first biosimilar of the rituximab reference product and was approved in Europe for all licensed RTX indications in February 2017 [1]. A phase I randomized controlled trial (RCT) of CT-P10 versus reference rituximab in patients with active RA demonstrated that the two drugs had equivalent pharmacokinetics after a single course of treatment and that their efficacy, pharmacodynamics, immunogenicity and safety were comparable up to Week 24 [2]. To allow comparison of CT-P10 versus reference rituximab, patients in the same phase I trial received a second course of treatment and were evaluated for efficacy, safety, pharmacokinetics, pharmacodynamics, and other clinical data for up to 72 weeks. These data demonstrate that the clinical profile of CT-P10 is comparable to reference rituximab in patients with RA over an extended treatment duration [3].

Biological drug evolution: improved awareness and pharmacovigilance required

Biosimilars/Research | Posted 08/09/2017

The safety profile of established biological drugs can alter over time following changes to manufacturing processes. However, healthcare professionals are often unaware of changes and there is a need for improved pharmacovigilance, according to a report published by researchers in Scotland, UK [1].

Rituximab biosimilar CT-P10 could save Europe Euros 90 million in its first year

Biosimilars/Research | Posted 01/09/2017

A recent publication in Advances in Therapy suggests that introducing CT-P10, a biosimilar of the anti-CD20 monoclonal antibody rituximab, would generate significant savings for European healthcare systems [1]. CT-P10 is approved by the European Medicines Agency (EMA) for all indications held by reference rituximab, including rheumatoid arthritis and haematological cancers, such as non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia. Although the therapeutic benefits of anti-CD20 therapy are well established, the cost of reference rituximab is thought to create barriers to patient access [2]. It is hoped that the introduction of more affordable biosimilars will help address this issue. Gulácsi L et al. therefore quantified the potential budgetary impact of introducing CT-P10 for the treatment of rheumatoid arthritis and CD20-positive cancers in 28 European countries [1].

Biological drug evolution: inadequate short-term clinical trials

Biosimilars/Research | Posted 01/09/2017

The safety profile of established biological drugs can alter over time following changes to manufacturing processes and short-term clinical trials fail to isolate adverse events, according to a report published by researchers in Scotland, UK [1].

Adello Biologics starts phase I trial for pegfilgrastim biosimilar

Biosimilars/Research | Posted 25/08/2017

US-based biosimilars specialist Adello Biologics has started a phase I clinical trial for a biosimilar version of Amgen’s Neulasta (pegfilgrastim).

Biosimilar pegfilgrastim highly similar to Neulasta

Biosimilars/Research | Posted 18/08/2017

Canada-based Apobiologix published analytical results demonstrating the similarity of their pegfilgrastim product to the US reference product, Amgen’s Neulasta (pegfilgrastim) [1].

Real-life data supports efficacy and safety of biosimilar filgrastim

Biosimilars/Research | Posted 18/08/2017

Biosimilars of filgrastim are widely used in the prophylaxis of chemotherapy‐induced (CIN) and febrile neutropenia (FN). However, there are limited observational data on the use of granulocyte colony-stimulating factor (G‐CSF) in non‐Hodgkin’s lymphoma (NHL) and its aggressive subtypes including diffuse large B‐cell lymphoma (DLBCL).

Biosimilar trastuzumab candidate shows ‘similarity’ to Herceptin

Biosimilars/Research | Posted 11/08/2017

Results of a phase III clinical study of Celltrion’s biosimilar trastuzumab candidate CT‑P6 demonstrated the ‘similarity’ of the efficacy and safety compared to the originator biological (Herceptin) in patients with HER2+ breast cancer [1].

US prescribers’ views on the naming and labelling of biologicals

Biosimilars/Research | Posted 14/07/2017

The Alliance for Safe Biologic Medicines (ASBM) has published the results of a survey in which they asked 400 US physicians for their views on the labelling of biosimilar medicines, and a separate survey in which they asked another 400 US physicians for their views on the naming of biosimilar medicines [1]. All those surveyed were prescribers of biological medicines. The surveys were carried out in the run up to the release of guidance from the US Food and Drug Administration (FDA) on the non-proprietary naming of biological products.

Real world switching data for etanercept biosimilar Benepali

Biosimilars/Research | Posted 14/07/2017

Real world evidence from a study of etanercept biosimilar Benepali (SB4) compared to Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept) have demonstrated ‘sustained efficacy and safety, and high acceptance and adherence in patients initiating treatment with Benepali (etanercept)’, according to Biogen.

Pharmocovigilance of rituximab in Argentina

Biosimilars/Research | Posted 07/07/2017

Novex is a rituximab medicamento biológico similar (similar biological medicines) approved in Argentina. According to Argentinian regulations such products need to implement an active pharmacovigilance programme. This requires regular reporting to the Argentinian regulatory agency Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration of Drugs, Foods and Medical Devices; ANMAT).

Trastuzumab biosimilar could reduce breast cancer treatment costs

Biosimilars/Research | Posted 30/06/2017

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

Biosimilars and sustainability

Biosimilars/Research | Posted 23/06/2017

Competition between brand-name biologicals and biosimilars has the potential to reduce future cancer costs, according to researchers from Italy [1].

Boehringer Ingelheim’s adalimumab biosimilar ‘equivalent’ to Humira

Biosimilars/Research | Posted 23/06/2017

Germany-based biologicals specialist Boehringer Ingelheim (Boehringer) announced on 14 June 2017 positive results from its pivotal phase III study of its candidate adalimumab biosimilar.

Biosimilar infliximab safe and effective in IBD

Biosimilars/Research | Posted 16/06/2017

A systematic review and meta-analysis of Celltrion/Hospira’s infliximab biosimilar, Remsima/Inflectra found it to be safe and effective in the treatment of inflammatory bowel diseases (IBD) [1].

Infliximab biosimilar coming closer to interchangeability

Biosimilars/Research | Posted 09/06/2017

Three studies presented at the Digestive Disease Week (DDW) 2017 have shown no significant differences in efficacy or safety endpoint. Two of the studies also specifically tested outcomes in patients switching from the originator infliximab product, Remicade, to the biosimilar version.

Predictive modelling of CIN prophylaxis with biosimilar filgrastim

Biosimilars/Research | Posted 09/06/2017

Granulocyte colony-stimulating factors (G-CSF) stimulate white blood cell production and as such are indicated in the prophylaxis of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). Risk models of CIN/FN to date focus on predictors measured at the start of chemotherapy. Aapro and colleagues used a dynamic approach of CIN/FN risk modelling at the start of each cycle.

How the FDA regulates biosimilars

Biosimilars/Research | Posted 02/06/2017

The advent of recombinant DNA-technology ushered in the development of novel therapeutic protein products that have become mainstays of treatment regimens against cancer, inflammatory disorders and other serious diseases and conditions. Recombinant therapeutic proteins are typically large, complex molecules that are produced in cultured cells and manufactured using complex, multistep purification processes. Despite some of these products being ‘off-patent’ for years, they remain among the most expensive pharmaceuticals in the US and the world. One approach that governments across the globe have taken to reduce healthcare costs is to give regulatory authorities the ability to approve biologicals using an abbreviated licensing pathway that includes achieving the rigorous standard of demonstrating ‘biosimilarity’ with an already approved biological product.

Positive phase III results for Sandoz’s adalimumab biosimilar

Biosimilars/Research | Posted 02/06/2017

A phase III study of a proposed adalimumab biosimilar (GP2017) from Sandoz has met its primary endpoint ‘demonstrating equivalent efficacy’ to AbbVie’s Humira (adalimumab).

Biosimilars in the treatment of inflammatory bowel disease

Biosimilars/Research | Posted 26/05/2017

Inflammatory bowel disease (IBD) is mainly characterized by two chronic, relapsing, immune-mediated inflammatory diseases of the gastrointestinal tract: Crohn’s disease and ulcerative colitis. Approximately 1.4 million Americans are affected by IBD and afflicted with recurrent symptoms of bloody diarrhoea, abdominal pain, bowel obstruction, and other co-morbid conditions. The introduction of biologicals, highly complex molecules manufactured from living organisms, was a revolutionary advance in treating threatening and life-debilitating inflammatory diseases. Biologicals, particularly those that target tumour necrosis factor (TNF) signalling, have provided IBD patients with an efficacious method of treatment with regards to symptom management and mucosal healing. Nevertheless, the rising prevalence of IBD worldwide and the ever-increasing cost burden of biologicals in the healthcare industry is alarming for insurance companies, clinicians and patients.

EMA guidance for NBCDs and products approved

Biosimilars/Research | Posted 26/05/2017

The European Medicines Agency (EMA) has published reflection papers on nanomedicines and their follow-on versions [1]. It has also published a wide range of other guidance, which outlines the technical requirements to demonstrate the quality, safety and efficacy of medicines that may also be applicable to non-biological complex drugs (NBCDs), according to authors Ehmann and Pita [2].

Danish infliximab switching study shows no difference

Biosimilars/Research | Posted 19/05/2017

A study published by researchers from Denmark has found that switching from originator to biosimilar infliximab has ‘no negative impact on disease activity’ [1].

Post-marketing experience with IBD biosimilars

Biosimilars/Research | Posted 19/05/2017

The introduction of anti-tumour necrosis factor-alpha (TNF-α) monoclonal antibodies (mAbs), about two decades ago, has revolutionized the management of inflammatory bowel disease (IBD). However, they are also expensive and their cost can lead to restricted access for many patients.

Accountability, safety and competition in biologicals markets

Biosimilars/Research | Posted 12/05/2017

Regulatory systems for drug approval aim to reduce the likelihood of drug-related safety problems, but cannot fully eliminate post-marketing safety events. Such safety problems can have substantial consequences for patient’s well-being. For example, the most severe class of recalls issued by the US Food and Drug Administration (FDA) occur about once per month, and have recently been increasing in frequency [1]. Post-marketing surveillance or pharmacovigilance systems enable monitoring of and response to safety problems that may be undetected before drugs reach the general market [2]. When a safety problem occurs, successful identification of the responsible firm, or accountability, depends on the information available to the pharmacovigilance effort [3, 4].

Computer modelling for glycoengineering of biosimilars

Biosimilars/Research | Posted 04/05/2017

In order to be approved by regulatory agencies, biosimilars are required to match all pharmacological properties of the originator protein drug to guarantee efficacy and alleviate safety concerns.

Prospective study finds switching to biosimilar infliximab safe

Biosimilars/Research | Posted 28/04/2017

A study of the infliximab biosimilar Remsima has, according to the authors, shown similar ‘safety and survival’ of biosimilar infliximab Remsima compared to the originator biological Remicade [1].

Rituximab biosimilar safe in advanced follicular lymphoma patients

Biosimilars/Research | Posted 21/04/2017

A study of the rituximab biosimilar CT‑P10 has, according to the authors, ‘demonstrated’ similar pharmacokinetics (PK) and safety when administered in combination with cyclophosphamide, vincristine and prednisone (CVP) in patients with newly diagnosed advanced follicular lymphoma (AFL) [1].

Harmonization of requirements for NBCDs across regions

Biosimilars/Research | Posted 21/04/2017

Efforts are being undertaken to continuously develop and harmonize the regulatory requirements for complex medicinal products across regions. Taking this into account, authors Ehmann and Pita believe the European Union (EU) network is ready for non-biological complex drugs (NBCDs) [1].

US pharmacists’ views on the naming and labelling of biologicals

Biosimilars/Research | Posted 14/04/2017

The Alliance for Safe Biologic Medicines (ASBM) has published the results of a survey determining the opinions of US pharmacists about the naming and labelling of biosimilars [1].

Italian study compares epoetin biosimilars and originator biologicals

Biosimilars/Research | Posted 14/04/2017

Recently, extensive discussion on the opportunity offered by biosimilars for the sustainability of the National Health Services has taken place in academic and regulatory contexts. The use of biosimilars continues to be limited, and the scepticism of prescribers and patients seem to be linked to the uncertainty of the risk-benefit profile of biosimilars. In the case of epoetins, used in the management of anaemia in the nephrology and oncology settings, the results of a recent study showed no difference between biosimilars and originators on relevant effectiveness and safety outcomes [1].

Pharmacovigilance of biologicals in Denmark

Biosimilars/Research | Posted 19/08/2016

As a result of the increasing use of biologicals and biosimilars in Denmark, the Ministry of Health (MoH) in partnership with the country’s regulatory agency has set up an action plan to monitor biologicals and improve pharmacovigilance, as well as to improve understanding among healthcare professionals and patients [1].

Filgrastim follow-on biological has similar efficacy and safety in breast cancer patients

Biosimilars/Research | Posted 07/04/2017

A study comparing two filgrastim formulations for controlling chemotherapy-induced neutropenia has reported similar efficacy, safety and non-inferiority of the biosimilar [1].