Biosimilars/Research

Is switching to biosimilar infliximab safe?

Biosimilars/Research | Posted 14/06/2019

Building on a number of studies on biosimilar infliximab for inflammatory bowel disease (IBD), a recent review shows switching to CT-P13 is safe, but more evidence is needed on switching back to originator and switching between biosimilars [1].

First subjects dosed in Australian phase I study of denosumab biosimilar

Biosimilars/Research | Posted 12/06/2020

Taiwan-based JHL Biotech announced on 18 May 2020 that the first group of subjects has been randomized and dosed in the week of 11 May 2020 in the company’s Australian phase I clinical trial of its candidate denosumab biosimilar (JHL1266) in healthy subjects.

Samsung Bioepis releases data on trastuzumab and ranibizumab biosimilars

Biosimilars/Research | Posted 05/06/2020

Samsung Bioepis has released follow-up data for its approved trastuzumab biosimilar Ontruzant, as well as interim results for its proposed Lucentis (ranibizumab) biosimilar.

Safety of switching between reference products and biosimilars

Biosimilars/Research | Posted 29/05/2020

The safety of switching a patient under chronic treatment with a reference biological to a biosimilar has been a topic of ongoing debate since the first biosimilar approval in Europe in 2006. The topic sparked further discussion with the arrival of the more complex monoclonal antibody biosimilars. Concerns have been raised that switching between highly similar but non-identical versions of a biological medicine might lead to increased immunogenicity and as such, impact treatment outcomes. The existing stakeholder uncertainty regarding the safety of switching may have been curbing the use of biosimilars in clinical practice and guidance to support healthcare professionals with clinical decision-making is needed.

Hepatobiliary events similar for SB4 and Enbrel in IJD

Biosimilars/Research | Posted 29/05/2020

According to a study carried out by researchers from Denmark, hepatobiliary adverse events occur at a similar frequency in patients treated with the etanercept biosimilar Benepali (SB4) compared to the originator product, Enbrel, in inflammatory joint disease (IJD) [1].

Do patent strategies delay market entry of biosimilar monoclonal antibodies in Europe?

Biosimilars/Research | Posted 22/05/2020

Patents have been shown to be the main determinant to guarantee market exclusivity of originator biologicals [1], with patent disputes causing uncertainty on a patent’s validity and subsequently potentially influencing launch dates of competitor products, such as biosimilars [2]. In addition, the launch date of a biosimilar might be affected by strategies for prolongation of exclusivity rights on the originator product, such as filing additional patents for a new formulation, new indication or new dosage regime [3].

Scientific evidence in development of trastuzumab biosimilar ABP 980

Biosimilars/Research | Posted 15/05/2020

ABP 980 (Kanjinti) is a biosimilar to trastuzumab reference product (RP) (Herceptin), a monoclonal antibody directed against human epidermal growth factor receptor 2 (HER2). A biosimilar is highly similar to a licensed biological with no clinically meaningful differences in safety, purity and potency [1, 2]. Kanjinti is approved in the US, European Union, and as trastuzumab BS [trastuzumab biosimilar 2] in Japan for all Herceptin indications, which include treatment of HER2 positive (HER2+) metastatic breast cancer, early breast cancer (EBC), and metastatic gastric cancer [3-5]. Development and approval were based on a totality of evidence (TOE) approach, involving stepwise generation of comparative analytical (structural and functional), preclinical, and clinical (pharmacokinetics [PK], pharmacodynamics [PD], efficacy, safety and immunogenicity) evidence [6].

Biosimilar education gaps in oncology

Biosimilars/Research | Posted 15/05/2020

A survey administered by the International Society of Oncology Pharmacy Practitioners (ISOPP) identifies key educational needs on biosimilars amongst its practitioners, including how to compare a biosimilar to an originator and how to manage switching [1].

Non-innovator biologicals in India: regulatory context and areas for improvement

Biosimilars/Research | Posted 04/05/2020

There are major regulatory lapses in the manufacturing of similar biologics in India. The use of scientific audits could strengthen the regulatory system and improve the provision of high quality biosimilars in the country, according to a recent opinion piece [1] by Dr GR Soni, which was published in GaBI Journal.

Clinical trials for adalimumab biosimilar SB5

Biosimilars/Research | Posted 04/05/2020

The clinical trials used to support the approval of Samsung Bioepis/Merck’s adalimumab biosimilar SB5 (Imraldi/Hadlima), were critically reviewed by authors from Argentina and the UK, with a special focus on rheumatoid arthritis (RA) [1].

Clinical trials for adalimumab biosimilar BI 695501

Biosimilars/Research | Posted 17/04/2020

The clinical trials, especially those in rheumatoid arthritis, used to support the approval of Boehringer Ingelheim’s BI 695501 (Cyltezo), were critically reviewed by authors from Argentina and the UK [1].

Clinical trials for adalimumab biosimilar ABP 501

Biosimilars/Research | Posted 10/04/2020

The clinical trials used to support the approval of Amgen’s ABP 501 (Amjevita/Amgevita/
Solymbic) were critically reviewed by authors from Argentina and the UK [1].

Clinical trials supporting the approval of adalimumab biosimilars

Biosimilars/Research | Posted 03/04/2020

Authors from Argentina and the UK critically review the evidence from trials of biosimilars in rheumatoid arthritis (RA) [1].

Assessment of biosimilarity for monoclonal antibodies

Biosimilars/Research | Posted 24/04/2020

How therapeutic monoclonal antibody biosimilars are assessed for biosimilarity, was discussed by authors from the National Institute of Health Sciences and the Yokohama University of Pharmacy in Japan. Their review covers the basic concept of biosimilar development as well as pharmacokinetic data obtained via non-clinical and clinical studies of biosimilar therapeutic antibodies [1].

Positive phase III results for Hisun’s adalimumab copy biological

Biosimilars/Research | Posted 10/04/2020

Positive results were reported from a phase III trial of an adalimumab copy biological, HS016, which compared the candidate adalimumab copy biological HS016 with originator adalimumab Humira for the treatment of active ankylosing spondylitis (AS) [1].

Cost savings from the use of biosimilars in Canada

Biosimilars/Research | Posted 27/03/2020

Analysis of the potential cost savings from the use of three biosimilars (filgrastim, infliximab and insulin glargine) in Canada shows that over CA$1 billion could have been saved in just a two-year period [1].

PK and PD similarity between pegfilgrastim biosimilar and Neulasta

Biosimilars/Research | Posted 20/03/2020

Hexal AG has published phase I results for its approved pegfilgrastim biosimilar [1-3].

Clinical and real-world data for switching to biosimilars

Asian specialists' recommendations for off-patent biologicals in IBD

Biosimilars/Research | Posted 19/07/2019

Gastroenterologists from across Asia have published a list of recommendations for the use of biologicals and off-patent biologicals in inflammatory bowel disease (IBD) in Asia [1].

Arguments against Alberta’s plans to switch patients to biosimilars

Biosimilars/Research | Posted 13/03/2020

In May 2019, the Canadian province of British Columbia introduced a policy of switching rheumatology patients to biosimilars [1]. Now, the province of Alberta is also considering plans to stop coverage of originator biologicals and switch patients to biosimilars for certain indications. The new policy, if introduced, will apply to the approximately 30,000 patients in Alberta living with inflammatory bowel disease (IBD) [2].

Tackling the challenge of safe automatic substitution of biologicals

Biosimilars/Research | Posted 13/03/2020

The costs of biologicals are challenging the sustainability of pharmacotherapy. Affordable biosimilars are expected to trigger competition within the biologicals market. Increasing real-world experience on biosimilars and clinical switching studies have led to position papers supporting the interchangeability of biosimilars with their reference products under the supervision of the prescriber [1]. However, the uptake of biosimilars has been poor in Finland, since physicians have been reluctant to prescribe biosimilars, especially in the outpatient setting. One option to stimulate the uptake of biosimilars is the automatic substitution of biologicals at the pharmacy level.

Efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501

Biosimilars/Research | Posted 22/06/2018

Adalimumab is the most commonly prescribed biological and is approved for rheumatoid arthritis as well as psoriasis, psoriatic arthritis, along with Crohn’s and ulcerative colitis. Its patent life terminated in 2016 in the US [1]. However, in the US AbbVie has stated that, although the composition of matter patent covering Humira expired in December 2016, non-composition of matter patents covering Humira expire no earlier than 2022. The company has therefore made settlement agreements with Amgen and Samsung Bioepis, delaying the launch of biosimilars until January 2023 [2, 3].

Reasons and solutions for the high cost of insulin in the US

Biosimilars/Research | Posted 21/02/2020

The most commonly used forms of analogue insulin cost 10 times more in the US than in any other developed country. In fact, the cost of insulin in the country has more than tripled in the past 10 years [1]. This has led to patients rationing their insulin; something that does not happen in other developed countries, but is common in the US.

Achieving fairer prices for generics and biosimilars

Biosimilars/Research | Posted 14/02/2020

Access to safe, effective, quality assured, and affordable essential medicines and vaccines for all has been identified as key to achieving universal health coverage and financial protection. However, this is not always the case, according to Alessandra Ferrario and colleagues from the Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Healthcare Institute, Boston, USA [1].

Failures when switching patients to biosimilar etanercept

Biosimilars/Research | Posted 07/02/2020

A ‘real-world’ study on switching patients from the originator etanercept, Enbrel, to the biosimilar Benepali (SB4) investigated the reasons why some patients switched back to the originator [1].

Law and ethics of switching to biosimilars in Canada

Biosimilars/Research | Posted 31/01/2020

With healthcare budgets in mind, governments and financial institutions across the globe are planning or implementing non-medical or ‘forced’ switches by cutting drug coverage for reference biologicals and funding only less expensive biosimilars. This is a subject fraught with issues related to both the law and the ethics of switching. Authors Blake Murdoch and Timothy Caulfield of the Health Law Institute, Faculty of Law, University of Alberta, Edmonton, Alberta, Canada, try to address how such issues might affect Canada [1].

Real-life clinical effectiveness of Razumab in wet AMD

Biosimilars/Research | Posted 24/01/2020

The multicentre, retrospective RE-ENACT 2 study evaluated the real-world effectiveness of ranibizumab biosimilar, Razumab, for the treatment of wet age-related macular degeneration (wet AMD). This report presents the results from a subgroup analysis of the RE-ENACT 2 study [1].

Biocad announces positive rituximab results and plans to enter EU market

Biosimilars/Research | Posted 17/01/2020

Russian biotechnology company Biocad has announced plans to enter the European market and has published positive results for its rituximab non-originator biological Acellbia (BCD-020).

Analytical similarity assessment of teriparatide biosimilar Terrosa

Biosimilars/Research | Posted 10/01/2020

Terrosa and Movymia (both developed under the code name RGB-10), were the first biosimilars of Eli Lilly’s osteoporosis biological Forteo/Forsteo (teriparatide) in Europe. Gedeon Richter and Stada Arzneimittel gained European Commission approval for Terrosa and Movymia in January 2017 [1] and launched the biosimilars in August 2019 [2]. Meanwhile, RGB-10 was also approved in other countries, including Switzerland and Japan.

Positive results for Bio-Thera’s arthritis copy biologicals

Biosimilars/Research | Posted 06/09/2019

China-based Bio-Thera Pharmaceuticals have begun a phase I trial for its Simponi copy biological and obtained positive results from a phase III trial of its Humira copy biological.

Positive trial results for Lannett’s insulin biosimilar

Biosimilars/Research | Posted 17/01/2020

US firm Lannett has completed a successful trial of their candidate insulin biosimilar, which was compared to Sanofi’s blockbuster insulin product Lantus.

NeuClone progress with ustekinumab and trastuzumab biosimilars

Biosimilars/Research | Posted 10/01/2020

Australian biosimilars firm NeuClone has started a phase I trial of their proposed ustekinumab biosimilar and announced positive results from a trial of their trastuzumab biosimilar.

Pharmacists must be ready to take the lead on biosimilars

Biosimilars/Research | Posted 13/12/2019

Pharmacists should take the lead in increasing the adoption of biosimilars in clinical practice, says a review of the implications of biosimilars for pharmacy practice. The review suggests that pharmacists in all settings can take a key role in advocating for biosimilars [1].

Use of pegfilgrastim copy biological Mecapegfilgrastim in neutropenia

Biosimilars/Research | Posted 06/12/2019

Italian oncologists report on studies carried out with a new pegfilgrastim copy biological, Mecapegfilgrastim (HHPG-19K) [1].

Biosimilar education for Canadian nurses

Biosimilars/Research | Posted 29/11/2019

In general, Canadian nurses are familiar with biosimilars. However, according to authors Sehdev et al., they may have knowledge gaps in their specific understanding, resulting in a significant unmet need for education.

Brazilian efficacy and safety data for biosimilar infliximab CT-P13 in the treatment of psoriasis and psoriatic arthritis

Biosimilars/Research | Posted 22/11/2019

Celltrion/Hospira’s infliximab biosimilar Remsima/Inflectra (CT-P13) was authorized by the European Medicines Agency (EMA) in 2013 [1] and by the US Food and Drug Administration (FDA) in 2016 [2].

Biologicals and biosimilar use in Asian patients with IBD

Biosimilars/Research | Posted 15/11/2019

The increasing incidence of inflammatory bowel diseases (IBD) has become a major challenge for gastroenterologists in some Asian countries, particularly China, Japan and Korea. This subject was discussed in the August 2019 issue of the Journal of Gastroenterology and Hepatology [1].

Samsung reveals positive trial results for bevacizumab biosimilar, but admits to failure with rituximab

Biosimilars/Research | Posted 15/11/2019

A phase III trial of Samsung Bioepis’ bevacizumab biosimilar has shown equivalence to reference drug Avastin (bevacizumab). However, the company has admitted to failures in its attempt to develop a rituximab biosimilar at a recent trial in the Seoul Central District Court.

Clinical data requirements for biosimilars in the EU: immunogenicity comparability

Biosimilars/Research | Posted 08/11/2019

The totality of evidence approach for biosimilars in the European Union (EU) was discussed in a review paper [1] using case studies to illustrate biosimilars for which differences were observed in different parts of the comparability exercise and the justification for why these differences did not preclude regulatory approval.

Biosimilars regulation in Canada: state of play

Biosimilars/Research | Posted 08/11/2019

A paper recently published in GaBI Journal provides an update on the regulation and reimbursement of biosimilars in Canada, including changes to the regulation on switching and processes for private plan reimbursement [1].

Clinical data requirements for biosimilars in the EU: efficacy comparability

Biosimilars/Research | Posted 08/11/2019

The European Medicines Agency (EMA) uses a totality of evidence approach in its regulatory review process for biosimilar approval. As part of this, the biosimilar should demonstrate that it does not have clinically meaningful differences from the originator biological, based on comparative clinical studies.

Clinical data requirements for biosimilars in the EU: PK and PD comparability

Biosimilars/Research | Posted 25/10/2019

In their article [1], authors from the Paul-Ehrlich-Institut, the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), discussed the totality of evidence approach for biosimilars in the European Union (EU) using case studies to illustrate biosimilars for which differences were observed in different parts of the comparability exercise and on the justification for why these differences did not preclude regulatory approval.

Positive real-world data for etanercept biosimilar Benepali

Biosimilars/Research | Posted 25/10/2019

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 9 October 2019 that it had presented positive real-world data from its etanercept biosimilar Benepali at the 2019 European Academy of Dermatology and Venereology (EADV) Congress [1].

Clinical data requirements for biosimilars in the EU: analytical comparability

Biosimilars/Research | Posted 18/10/2019

For biosimilars, the regulatory review process is based on the totality of evidence generated in support of biosimilarity.

Trial of bevacizumab copy biological with novel antibody targeting PD-1

Biosimilars/Research | Posted 18/10/2019

China-based Shanghai Henlius Biotech (Henlius) is recruiting patients for a study that will investigate a proposed bevacizumab copy biological in combination with a novel antibody targeting PD-1.

Clinical data requirements for biosimilars in the EU

Biosimilars/Research | Posted 11/10/2019

In their article [1], authors from the Paul-Ehrlich-Institut, the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) discussed the clinical data requirements for biosimilars in the European Union (EU).

Biosimilars applications reviewed in the EU

Biosimilars/Research | Posted 04/10/2019

The European Union (EU) was the first to establish a legal framework for biosimilars back in 2003 [1]. Since the European Medicines Agency (EMA) approved its first biosimilars in 2006, the agency has issued new guidelines and updated its existing guidelines based on new evidence and rapid advances in analytical sciences [2].

Switching from originator to biosimilar epoetins appears to be effective and safe

Biosimilars/Research | Posted 04/10/2019

Switching between biological drugs during pharmacological treatment leads prescribers and patients to ask themselves the question: ‘Will it be safe?’. In particular, when switching from an originator to a biosimilar, the belief that this choice is shaped by economic reasons feeds suspicions and controversies.

Switching from originator infliximab to CT-P13: real-world data with 24 months of follow up

Biosimilars/Research | Posted 27/09/2019

A prospective observational study with moderate-to-severe Crohn’s disease (CD) and ulcerative colitis (UC) patients switched from infliximab to CT-P13 treatment was carried out at Hospital Universitario Virgen Macarena, Seville, Spain, and reviewed up to 24 months. The primary endpoint was to analyse the loss of response to infliximab after switching. A loss of response was considered as the Harvey–Bradshaw (HB) index >4 for CD, partial Mayo score (PMS) >2 for UC, steroid use or surgery related to the activity of the disease and/or infliximab dose increase during the follow up.

Screening protein surface biosimilarity of rituximab using aptamers

Biosimilars/Research | Posted 20/09/2019

Among the many features needed to prove sufficient biosimilarity to a licensed drug produced in living organisms, is coherency of the three-dimensional structure. The integrity thereof is vital for the efficacy and safety of a biopharmaceutical, and even small and local structural changes may result in loss of function or cause undesired side effects for the patients. Reliable assessment of the detailed three-dimensional structure, however, requires laborious analytical methods like Nuclear Magnetic Resonance (NMR) or X-ray crystallography. Another option, epitope characterization using antibodies specific for the target biologicals, is restricted by the availability of appropriate, well-characterized antibody panels and typically involves animal experiments.

More positive phase III results for rituximab biosimilar ABP 798

Biosimilars/Research | Posted 13/09/2019

Biotech giant Amgen, and its partner Allergan, announced on 22 August 2019 positive data from a ‘top-line’ phase III study of its rituximab biosimilar (ABP 798) compared to Rituxan (rituximab) in non-Hodgkin's lymphoma (NHL) patients.

Clinical comparability between rituximab biosimilar RTXM83 and rituximab in diffuse large B-cell lymphoma patients

Biosimilars/Research | Posted 13/09/2019

The arrival of biosimilars represents more affordable alternatives for patients in several countries, increasing their access to costly biological treatments [1]. The positive impact of biosimilars on the financial sustainability of healthcare systems has been recognized by several haemato-oncological societies.

Switching from reference to biosimilar infliximab in ankylosing spondylitis patients

Biosimilars/Research | Posted 06/09/2019

Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease that affects the spine and the sacroiliac (SI) joints. AS is a type of seronegative spondyloarthropathy [meaning that tests show no presence of rheumatoid factor (RF) antibodies] or axial spondyloarthritis (SpA), i.e. it is a chronic, autoinflammatory disease predominantly affecting the axial skeleton [1].

Perceptions of biosimilars among US cancer patients

Biosimilars/Research | Posted 30/08/2019

Amid increasingly expensive cancer treatments, researchers in the US explored perceptions of generic drugs among a group of 75 patients, in findings presented alongside the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

Comparison of darbepoetin alfa and epoetin alfa for the treatment of renal anaemia

Biosimilars/Research | Posted 30/08/2019

Darbepoetin alfa (DA-α) manufactured by Hetero Biopharma (Hetero) is the first long-acting erythropoiesis-stimulating agent with extended dosing intervals. This gives it an advantage over epoetin alfa (EPO) and epoetin beta. It also has a half-life three-fold longer than that of EPO.

Safety of SC form of infliximab biosimilar CT-P13

Biosimilars/Research | Posted 23/08/2019

Positive results for Celltrion Healthcare’s (Celltrion) subcutaneous (SC) formulation of its infliximab biosimilar, CT-P13 (Remsima), have been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].

Positive phase III results for bevacizumab copy biological IBI305

Biosimilars/Research | Posted 16/08/2019

Innovent Biologics (Innovent) has presented positive phase III results for its bevacizumab copy biological IBI305 at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO).

Extensive characterization of biosimilars: a pegylated filgrastim study

Biosimilars/Research | Posted 16/08/2019

Pegfilgrastim, is a 38 kDa, pegylated form of filgrastim, with a 20 kDa monomethoxypolyethylene glycol (mPEG) molecule covalently bound to the N-terminal methionyl residue of filgrastim developed by Amgen. Attachment of the mPEG-moiety enables a longer half-life, that enables only once-per-cycle administration for the management of chemotherapy-induced neutropenia. This results in a much simpler treatment regime for patients. The biosimilar version of pegfilgrastim developed by Intas Pharmaceuticals, and marketed by Accord Healthcare under the brand name Pelgraz, is one of the first pegfilgrastim biosimilars to be approved for market authorization in the European Union (EU) [1].

Distinct suffixes will aid biosimilar competition, says new research

Biosimilars/Research | Posted 09/08/2019

The differential naming of originator and biosimilar products supports accurate pharmacovigilance and promotes biosimilar uptake, finds a literature review recently published in GaBI Journal [1].

Real-world data on switching of etanercept biosimilars

Biosimilars/Research | Posted 09/08/2019

Real-world and clinical data from different studies involving switching to etanerept biosimilars were presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].

Long-term safety results for adalimumab biosimilar

Biosimilars/Research | Posted 02/08/2019

ABP 501 is an adalimumab biosimilar which was compared to reference adalimumab in a 24-week phase lll study demonstrating equivalent efficacy and similar safety and immunogenicity [1]. The results of this clinical trial, along with the totality of evidence from analytical and biofunctional evaluation, lead to the approval of this adalimumab biosimilar for rheumatoid arthritis in the European Union and the US. ABP 501 is marketed as Amgevita in Europe and other markets. However, it will not be available in the US until 2023 due to an agreement between Amgen, the developer of the biosimilar, and AbbVie who manufactures the originator product, Humira (adalimumab) [2].

Positive phase III data for adalimumab copy biologicals

Biosimilars/Research | Posted 02/08/2019

Positive phase III data for adalimumab copy biologicals has been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].

Positive results for rituximab non-originator and copy biologicals

Biosimilars/Research | Posted 26/07/2019

Positive results for the rituximab non-originator biological BCD-020 (AcellBia) and for the rituximab copy biological HLX01 (Hanlikon) have been presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1, 2].

Positive phase III results for trastuzumab biosimilar HD201

Biosimilars/Research | Posted 26/07/2019

Singapore-based Prestige BioPharma (Prestige) announced on 24 June 2019 positive phase III data for its trastuzumab biosimilar, HD201. The results, according to Prestige, ‘confirm the similarities between HD201 and trastuzumab’.

Positive phase III results for trastuzumab follow-on biological Zedora

Biosimilars/Research | Posted 19/07/2019

Results of a post-marketing study of Biocon and Mylan’s trastuzumab biosimilar Zedora (MYL-1401O) compared to Herceptin (trastuzumab) has shown equivalent safety data to the originator biological in breast and gastric cancer, according to the authors [1].

Real-world data confirms safety of infliximab biosimilar CT-P13

Biosimilars/Research | Posted 19/07/2019

Positive real-world data has been presented for Celltrion’s infliximab biosimilar CT P13 at the European Congress of Rheumatology 2019 (EULAR 2019).

How local policy measures and practices influence originator biological and biosimilar market dynamics in Sweden

Biosimilars/Research | Posted 21/06/2019

The licensing of biologicals, including biosimilars, in Europe is centralized via the European Medicines Agency (EMA). Subsequently, individual European Member States are responsible for pricing, reimbursement and policies on market entry and use of medicines. This decentralized responsibility results in diverging approaches towards market entry and uptake of biosimilars and contributes to variation in the use of biosimilars across European countries, and even within countries differences in biosimilar uptake levels exist. The latter is the case for the 21 counties of Sweden, implying that decisions taken by their county councils play a role in market access of biosimilars, alongside policy measures and incentives provided at the national level.

Recommendations for similar biotherapeutic products published by Latin American MS experts

Biosimilars/Research | Posted 21/06/2019

Recommendations for the use of similar biotherapeutic products for multiple sclerosis (MS) have been issued by a group of experts from Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Peru, Uruguay and Venezuela.

Positive phase I results for Bio-Thera’s bevacizumab copy biological

Biosimilars/Research | Posted 21/06/2019

China-based Bio‑Thera Solutions (Bio‑Thera) has published phase I results for its candidate bevacizumab copy biological, BAT1706 [1].

Biosimilars to replace older biologicals for IBD

Biosimilars/Research | Posted 07/06/2019

Biosimilars will gradually replace older biological drugs for IBD, however, issues – such as the safety of multiple switches – remain, says a recent assessment published in Digestive Diseases and Sciences [1].

Positive results for rituximab copy biological IBI301

Biosimilars/Research | Posted 31/05/2019

US-based pharma giant Eli Lilly, and its partner China-based Innovent Biologics (Innovent), announced on 7 May 2019 positive data from two clinical studies of their rituximab copy biological (IBI301) compared to Rituxan (rituximab).

GaBI Journal is the number one journal publishing on biosimilars

Biosimilars/Research | Posted 24/05/2019

The first ever global bibliometric analysis on biosimilars finds that GaBI Journal is the number one journal publishing on biosimilars. The study also shows that research on biosimilars is increasing, but is currently dominated by countries in the West such as the USA [1].

BiosanaPharma starts phase I trial for omalizumab biosimilar in Australia

Biosimilars/Research | Posted 24/05/2019

Dutch biosimilars developer BiosanaPharma announced on 21 February 2019 that it had received permission from the Australian Bellberry Human Research Ethics Committee (HREC) to start a phase I clinical trial of their first pipeline product, omalizumab.

ASCO/ASH give recommendations for biosimilar ESAs

Biosimilars/Research | Posted 17/05/2019

Recommendations for biosimilar erythropoiesis-stimulating agents (ESAs) in the management of cancer-associated anaemia have been issued by the American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH).

Biosimilars education still needed for US and EU clinicians

Biosimilars/Research | Posted 10/05/2019

A review of the literature has concluded that healthcare providers are still cautious when it comes to biosimilars and that clinician-directed education is still needed to increase biosimilar knowledge, facilitate prescribing changes and increase use of biosimilars [1].

Pharmacokinetic assessment of biosimilar therapeutic monoclonal antibodies

Biosimilars/Research | Posted 10/05/2019

Comparison of the clinical pharmacokinetic (PK) profile of a biosimilar with that of the reference product is an important step in the development of biosimilars. In a recent review, Ishii-Watabe and Kuwabara outline key considerations for the comparative studies required for biosimilar development, focusing on the clinical PK profiles of biosimilar therapeutic monoclonal antibodies (mAbs) and their reference products [1].