Biocon Biologics, Viatris Inc. get CHMP nod for Abevmy, a biosimilar to Avastin

Biocon Biologics Ltd., a subsidiary of Biocon Ltd. announced on Monday the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its biosimilar Bevacizumab,co-developed with Viatris, to be marketed as Abevmy (injection bevacizumab 100mg and 400mg).
Abevmy is abiosimilar to Roche's Avastin, prescribed for all indications including metastatic colorectal carcinoma, metastatic breast cancer, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer as part of a specific regimen, it said.

The decision of the European Commission is expected in May 2021, which, when approved, will grant marketing authorisation in the 27 European Union member countries and European Economic Area member states of Norway, Iceland and Liechtenstein, a company statement said.

For the U.K., the Medicines and Healthcare Products Regulatory Agencys "reliance procedure" will be followed, and the U.K. marketing authorisation can be expected shortly after the EC decision, it was stated.