Biosimilars

FDA accepts application for etanercept biosimilar

Biosimilars/News | Posted 09/10/2015

Sandoz, the generics division of Novartis, announced on 2 October 2015 that the US Food and Drug Administration (FDA) had accepted its application for its etanercept biosimilar (GP2015).

Another infliximab switching trial started

Biosimilars/News | Posted 02/10/2015

In The Netherlands another study has been initiated into the effects of switching patients from originator infliximab to biosimilar infliximab.

Biosimilar epoetin-α as effective as originator in anaemia treatment

Biosimilars/Research | Posted 02/10/2015

A study by researchers in Italy has concluded that biosimilar epoetin‑α appears to be comparable to originator epoetin‑α plus liposomal iron (Sideral), vitamin B12 and folates in terms of efficacy and safety for the treatment of refractory anaemia [1].

Biosimilar etanercept safe and effective

Biosimilars/Research | Posted 02/10/2015

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

Biosimilars/Research | Posted 25/09/2015

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

Biosimilars/News | Posted 25/09/2015

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

Biosimilars/General | Posted 25/09/2015

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

Biosimilars/News | Posted 18/09/2015

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

Biosimilars/Research | Posted 18/09/2015

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

Biosimilars/General | Posted 18/09/2015

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.