Biocon arm receives EMA approval to manufacture biosimilar Bevacizumab at Bengaluru facility
Bengaluru: Biocon Biologics Ltd, a global, fully 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 will provide significant additional capacity to address patients’ needs across markets in Europe. The facility has previously been approved to manufacture biosimilar Trastuzumab in September 2022.
The Company also announced that EMA has renewed its Good Manufacturing Practice (GMP) Certificates of Compliance for its biosimilars manufacturing facility at 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.
Medical Dialogues team had earlier reported that Biocon Sdn Bhd., a step-down subsidiary of Biocon Biologics Limited had received a communication from the U.S. Food and Drug Administration (FDA) pursuant to its July 2023 cGMP inspection at its insulins manufacturing facility at Johor, Malaysia.
Read also: Biocon Biologics arm gets OAI status from USFDA for Malaysia insulin facility
Biocon Limited, publicly listed in 2004, is an innovation-led, global biopharmaceutical company. It 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.
