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Biocad announces the trastuzumab biosimilar approval in Russia

The trastuzumab biosimilar, to be marketed under the trade name HERtiCAD, is the first trastuzumab biosimilar to receive authorization from the Russian regulatory body. The market authorization of the ...

First Etanercept biosimilar Benepali receives EU approval

The joint venture between Biogen and Samsung BioLogics, Samsung Bioepis, has been granted European Commission (EC) approval for Benepali, an etanercept biosimilar referencing Enbrel. Benepali® has been ...

Amgen Biosimilars: First submission for Humira biosimilar in the United States

Amgen announced the submission of a Biologics License Application (BLA) with the United States FDA for ABP 501, a biosimilar candidate to Humira (adalimumab). Amgen believes this submission is the first ...

Samsung Bioepis wins EMA nod for the first etanercept biosimilar in the European Union

Samsung Bioepis Co., Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Benepali – a biosimilar version of ...