Biosimilars/News
FDA delays meeting to evaluate infliximab biosimilar
The US Food and Drug Administration (FDA) has postponed a meeting of its Arthritis Advisory Committee, which was to discuss an infliximab biosimilar.
Accord launches biosimilar filgrastim in Europe
Generics company Accord Healthcare (Accord) has announced the launch of their first European approved biosimilar Accofil (filgrastim), indicated for the treatment of chemotherapy induced neutropenia.
Hospira and Pfenex to collaborate on ranibizumab biosimilar
US-based injectables specialist Hospira and US biotechnology firm Pfenex announced on 10 February 2015 that they had entered into an agreement to exclusively develop and commercialize for worldwide sales PF582 (ranibizumab), Pfenex’s leading biosimilar candidate.
FDA advisers to consider infliximab biosimilar
The US Food and Drug Administration (FDA) revealed in a Federal Register publication on 10 February 2015 that it has asked advisers to review a second biosimilar application.
Torrent licenses three ‘similar biologics’ from Reliance
Torrent Pharmaceuticals (Torrent) announced on 25 December 2014 that it had made an exclusive licensing agreement with fellow Indian drugmaker Reliance Life Sciences (Reliance) for the marketing of three ‘similar biologics’ in India.
FDA advisers recommend approval of filgrastim biosimilar
US Food and Drug Administration (FDA) advisers have voted unanimously to recommended approval for Sandoz’s biosimilar version of Amgen’s Neupogen (filgrastim), a development that could make complex biological therapies more readily accessible in the US.
Merck KGaA plans further investment in biosimilars
German pharma giant Merck KGaA announced on 18 September 2014 plans to step up investments in biosimilars during 2015.
Japanese approval for insulin glargine biosimilar
Partners Eli Lilly and Boehringer Ingelheim confirmed on 19 January 2015 that they had received Japanese regulatory approval for their biosimilar insulin glargine product (LY2963016).
Norwegian study may be slowing adoption of biosimilar infliximab
Norway is funding clinical studies in which patients will be switched from originator biological drugs to biosimilars [1]. However, some have speculated that the NOR-SWITCH study is actually slowing the adoption of biosimilar infliximab in Norway.
Adalimumab similar biologic launched in India
Indian generics maker Zydus Cadila announced on 9 December 2014 the launch of its adalimumab similar biologic in India.
