Biocon Biologics Ltd. (BBL), a global, integrated biosimilars company and a subsidiary of Biocon Ltd., has received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its new, world-class, multi-product monoclonal antibodies (mAbs) drug substance facility at Bengaluru.
This approval would provide significant additional capacity to address patients’ needs across markets in Europe. Bevacizumab is used to treat health conditions like colorectal cancer, lung cancer, and ovarian cancer, as per the company.
The Bengaluru facility has previously been approved to manufacture biosimilar Trastuzumab in September 2022. Biocon said that EMA has also renewed its Good Manufacturing Practice (GMP) certificate of compliance for its biosimilar manufacturing facility in Bengaluru and its insulin facility in Malaysia following routine GMP inspections. These certificates were issued by the Health Products Regulatory Authority (HPRA), Ireland, on behalf of EMA, the company said in a statement on Monday.
