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Biocon Biologics Ltd, a subsidiary of Biocon Ltd, has announced that Abevmy 100 & 400 mg, 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.
In a regulatory filing to exchanges, the company said that Abevmy 100 & 400 mg, a biosimilar Bevacizumab, 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.
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The centralised marketing authorisation granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
A Biocon Biologics spokesperson said, “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. This approval is an outcome of a great team effort and years of hard work and underlines our commitment to expand affordable access to life-saving biosimilars and make an enduring impact on global health.”
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