Biosimilars/News
FDA accepts application for pegfilgrastim biosimilar
Sandoz, the generics division of Novartis, announced on 18 November 2015 that its regulatory submission for its proposed pegfilgrastim biosimilar had been accepted by the US Food and Drug Administration (FDA).
Infliximab price wars
Merck has reportedly slashed the price of its blockbuster Remicade (Infliximab) in the UK in order to fight off growing competition from infliximab biosimilars.
Celltrion submits rituximab biosimilar application to EMA
South Korean biotechnology company Celltrion has, according to Business Korea, submitted a second biosimilar application to the European Medicines Agency (EMA).
Formycon starts phase III trial for ranibizumab biosimilar
German biosimilars companies Formycon and Bioeq announced on 7 October 2015 that they had initiated a pivotal phase III clinical trial with their candidate ranibizumab biosimilar (FYB201).
Boehringer Ingelheim stops biosimilar rituximab development
Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) has reportedly halted clinical development for its biosimilar version (BI 695500) of Roche’s blockbuster leukaemia treatment Rituxan/MabThera (rituximab).
Insulin glargine biosimilar in US delayed until end 2016
Pharmaceutical majors Eli Lilly and Sanofi announced on 28 September 2015 that the two companies had agreed to end the legal dispute over biosimilar insulin glargine in the US and to discontinue similar disputes worldwide.
Baxalta and Momenta start phase III trial for adalimumab biosimilar
Baxalta – a spinoff company from Baxter International – and US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 5 October 2015 that they had started a phase III clinical trial for their adalimumab biosimilar (M923) in patients with chronic plaque psoriasis.
FDA accepts application for etanercept biosimilar
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
In The Netherlands another study has been initiated into the effects of switching patients from originator infliximab to biosimilar infliximab.
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.
