Samsung Bioepis has marketing application for Humira biosimilar accepted in Europe

18 July 2016

South Korean drug developer Samsung Bioepis has had its marketing authorization application (MAA) for a biosimilar candidate referencing big-selling arthritis drug Humira (adalimumab) accepted for review by the European Medicines Agency (EMA).

The news comes just days after the US Food and Drug Administration’s Arthritis Advisory Committee unanimously recommended for approval the Humira biosimilar being developed by US biotech Amgen (Nasdaq: AMGN).

Samsung Bioepis, a joint venture between Korean conglomerate Samsung and US biotech Biogen (Nasdaq: BIIB), already has two anti-TNF biosimilars approved in Europe.

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