FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Amgen and Allergan’s Avastin Biosimilar Gets EMA Nod

Jan. 25, 2018

The European Medicines Agency has cleared Amgen and Allergan’s Mvasi, the first biosimilar of Roche’s Avastin.

The agency cleared Mvasi for several indications including colon and rectal carcinoma, breast cancer and cervical cancer, basing the approval on clinical trial results that found the drug was equivalent in terms of efficacy, safety and immunogenicity.

The drug secured U.S. approval last September. It is the first product from the collaboration between the two companies to reach either market.

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