The nod came following the positive recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency, it said.
PTI
April 26, 2021 / 10:31 AM IST
Biocon
Biocon Biologics Ltd., a subsidiary of Bengaluru-headquartered 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.
The nod came following the positive recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency, it said.
Abevmy 100 & 400 mg is approved for the treatment inmetastatic colorectal carcinoma, metastatic breast cancer, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer as part of a specific regimen, the company said.
The centralised marketing authorisation granted by the EC is valid in all EU Member States as well as in the European Economic Area countries Iceland, Liechtenstein and Norway, it was stated.
“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,” a Biocon Biologics spokesperson said.
The addition of biosimilar Bevacizumab will strengthen the company”s portfolio of biosimilars for cancer in the EU, which include biosimilar Trastuzumab and biosimilar Pegfilgrastim, the spokesperson said.