Biocon Biologics and Viatris Inc. receive CHMP nod for Abevmy
Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) 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 the 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 indicators including metastatic colorectal carcinoma, metastatic breast cancer, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and rectal cancer as part of a specific regimen.
The decision of the European Commission (EC) is anticipated in May 2021, which, when Approved, will give marketing authorization in the 27 European Union (EU) member nations and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. For your U.K., the Medicines and Healthcare Products Regulatory Agency's"reliance procedure" will be followed closely, and also the U.K. marketing authorization can be anticipated shortly following the EC decision.
Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Biologics, stated: "CHMP's Decision to recommend approval of our biosimilar Bevacizumab brings us a step closer to enable affordable access for this biologic therapy for cancer patients at the EU and our spouse Viatris. It's an outcome of our commitment to expand access for individuals leveraging our science and worldwide scale production to get a range of biosimilars. During bTrastuzumab and bPegfilgrastim we are already making a difference to the lives of cancer sufferers in many EU countries. We look forward to a last decision in the European Commission approving biosimilar Bevacizumab, which will add to our efforts in cancer care."
Abevmy, bBevacizumab, is a recombinant "humanized" monoclonal antibody which selectively binds to human vascular endothelial growth factor (VEGF) and neutralizes its biologic activity. Bevacizumab inhibits the formation of tumor vasculature, therefore Inhibiting tumor growth.