Biosimilars/Research

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.