Biocon subsidiary and Viatris secure CHMP nod for Abevmy

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.

Biocon Biologics, a subsidiary of Biocon, announced 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 100 mg and 400 mg).

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.

Shares of Biocon rose 0.90% to Rs 393.50 on BSE. Biocon is an innovation-led global biopharmaceuticals company. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as generic formulations in the US and Europe.

Biocon's consolidated net profit fell 19% to Rs 186.60 crore on 5.9% rise in net sales to Rs 1,851 crore in Q3 FY21 over Q3 FY20.

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