Biocon Biologics, Viatris get CHMP nod for Abevmy
Bengaluru: Biocon Biologics, a subsidiary of Biocon announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the marketing authorization of their biosimilar Bevacizumab, co-developed with Viatris, to be marketed as Abevmy (injection bevacizumab 100mg and 400mg).
Abevmy is a biosimilar 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.
The decision of the European Commission (EC) is expected in May 2021, which, when approved, will grant marketing authorization in the 27 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. For the U.K., the Medicines and Healthcare Products Regulatory Agency's "reliance procedure" will be followed, and the U.K. marketing authorization can be expected shortly after the EC decision.
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