Avastin biosimilar filed with EMA

3 December 2016

A Marketing Authorization Application (MAA) to the European Medicines Agency for ABP 215, a biosimilar candidate to Swiss pharma major Roche’s blockbuster cancer drug Avastin (bevacizumab).

The filers, Amgen (Nasdaq: AMGN) and partner Allergan (NYSE:AGN), say they believe this submission is the first bevacizumab biosimilar application filed with the EMA. The companies filed for approval of their Avastin biosimilar with the US Food and Drug Administration last month. Samsung Bioepis, Pfizer and Biocon/Mylan have candidates in late-stage development.

Roche has previously insisted it has patent protection for its brand until 2019 in the USA and 2022 in Europe.

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