Biocon Biologics, Viatris get EC approval for Abevmy
Bengaluru: 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 authorization approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
Abevmy 100 & 400 mg, a biosimilar Bevacizumab, is approved for the treatment in metastatic colorectal carcinoma, metastatic breast cancer, nonsmall-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer as part of a specific regimen.
The centralized marketing authorization 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.
"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," the company said in a statement
Biocon Limited is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune diseases.
The company 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.