Biosimilars/News
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.
Mabion starts phase III trial for rituximab biosimilar
Polish biologicals company Mabion announced on 25 November 2014 that it had received the consent of the appropriate regulatory authorities in Croatia, Bosnia and Herzegovina, Serbia and Poland to start a phase III clinical trial for its rituximab biosimilar (MabionCD20) in patients with diffuse large B-cell lymphoma.
Hospira submits application to FDA for epoetin alfa biosimilar
US-based injectables specialist Hospira announced on 12 January 2015 that it had submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its epoetin alfa biosimilar Retacrit.
Apotex pegfilgrastim biosimilar under FDA review
Canada-based Apotex announced on 17 December 2014 that the US Food and Drug Administration (FDA) had accepted for filing the company’s application for a biosimilar version of Amgen’s Neulasta (pegfilgrastim).
