Biocon Biologics gets EMA nod to manufacture cancer drug in India

Bengaluru, June 24: Biocon Biologics, a subsidiary of Biocon, on Monday got approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab in India. The company, in a statement, said that the biosimilar Bevacizumab will be manufactured at its new multi-product monoclonal antibodies (mAbs) drug substance facility in Bengaluru.

This approval will provide significant additional capacity to address patients' needs across the markets in Europe. The facility has previously got approval to manufacture biosimilar Trastuzumab in September 2022. Further, the facility also received Good Manufacturing Practice (GMP) Certificates of Compliance by the EMA, Biocon said.

The GMP certificates, issued by the Health Products Regulatory Authority (HPRA), Ireland, on behalf of EMA, were also provided to its insulin facility in Malaysia. The GMP certifications in India and Malaysia "reflect Biocon Biologics' continued compliance with the highest standards of quality and our unwavering commitment to addressing patient needs globally", a company spokesperson said, in the statement.