Biosimilars
Biosimilar etanercept safe and effective
In a study funded by Samsung Bioepis (a Biogen and Samsung joint venture), their candidate etanercept biosimilar (SB4) has been found to be safe and well tolerated and to be equivalent in terms of efficacy compared to Enbrel (etanercept) in patients with rheumatoid arthritis (RA) [1].
Positive phase III results for bevacizumab biosimilar
Results of a phase III trial have demonstrated the similarity of partners Amgen and Allergan’s biosimilar bevacizumab candidate (ABP 215) to Avastin in patients with advanced non-small cell lung cancer (NSCLC).
Biosimilar production in Malaysia
Malaysian biotech firm Inno Bio Ventures has announced the signing of a memorandum of understanding (MoU) with Iranian firm Aryogen Biopharma. The agreement will lead to the production of the first Malaysian-made biosimilars for the local and regional market.
Dutch medicines agency aims to clarify biosimilars confusion
The Dutch Medicines Evaluation Board (MEB) has further clarified its position on biosimilars since its last update in March 2015. The MEB had previously raised concerns among patient groups and professional organizations with the announcement that biosimilars had no relevant differences to originators.
Biosimilar insulin launched in the UK
Eli Lilly and Boehringer Ingelheim announced on 26 August 2015 the UK launch of their biosimilar insulin glargine, Abasaglar.
Pharmacoeconomic modelling of biosimilars in the US
There are many challenges and uncertainties associated with the introduction of biosimilars to the US. To try and address these, authors from the Partnership for Health Analytic Research developed a conceptual framework to provide guidance in modelling biosimilars in the US setting [1].
Biosimilars applications under review by EMA – August 2015
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
Comments on FDA’s guidance on naming biologicals
The US Food and Drug Administration (FDA) issued a draft guidance on the non-proprietary naming of biological products on 27 August 2015 [1], but not everyone is happy with the proposals made by the agency.
Biosimilar etanercept approved in South Korea
US pharma giant Merck and South Korean biosimilars maker Samsung Bioepis announced on 8 September 2015 the approval of their biosimilar etanercept product Brenzys by the Ministry of Food and Drug Safety (MFDS) in Korea.
Etanar as effective as adalimumab and infliximab in rheumatoid arthritis
A study of Etanar – an etanercept similar biotherapeutic product – has shown that it is as effective as adalimumab and infliximab in a cohort of patients with rheumatoid arthritis in a real-life setting [1].
