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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.

Hanwha to transfer biosimilar etanercept technology to Merck

South Korea’s Hanwha Chemical Corporation (Hanwha) has reportedly signed a contract with US pharma giant Merck to export the technology to make its biosimilar etanercept drug.

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).

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.

Biosimilar etanercept submitted for approval in EU

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 21 January 2015 that its etanercept biosimilar candidate, SB4, had been accepted for review by the European Medicines Agency (EMA).

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.

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