Biocon Biologics, a global biosimilars company and a subsidiary of Biocon Ltd has received approval from European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab, a type of targeted cancer drug treatment in its new 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 company 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.
Good manufacturing practice describes the minimum standard that a medicine manufacturer must meet in their production processes. The EMA coordinates these inspections to verify that a medicine manufacturer complies to these minimum standards.
The facility has previously been approved to manufacture biosimilar Trastuzumab in September 2022.