NEW DELHI, Apr 26: Biotechnology firm Biocon on Monday said its arm Biocon Biologics and Viatris have received approval from European Commission for their product Abevmy, used for treatment of cancer.
Abevmy is a biosimilar to Roche’s Avastin, is approved for treatment in metastatic colorectal carcinoma, metastatic breast cancer, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer as part of a specific regimen.
In a regulatory filing, Biocon said “Abevmy – a biosimilar of Bevacizumab co-developed with Viatris Inc. – has received marketing authorisation approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency”.
Biocon said the centralised marketing authorisation granted by the European Commission is valid in all European Union member states as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
“The European Commission’s approval of our biosimilar Bevacizumab will enable us to offer this biologic therapy to cancer patients in the EU along with our partner Viatris. The addition of biosimilar Bevacizumab will strengthen our portfolio of biosimilars for cancer in the EU, which include biosimilar Trastuzumab and biosimilar Pegfilgrastim,” Biocon Biologics said.
(PTI)
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