EMA Approval Boosts Biocon's mAbs Production Capabilities In India

Biocon Biologics, a branch of Biocon, has obtained authorization from the European Medicines Agency (EMA) to produce the biosimilar Bevacizumab at its new multi-product monoclonal antibodies (mAbs) drug substance plant in Bengaluru. This facility had previously been sanctioned to manufacture the biosimilar Trastuzumab in September 2022.

Additionally, the company announced that the EMA has renewed its Good Manufacturing Practice (GMP) Certificates of Compliance for its biosimilar production plant in Bengaluru and its insulin production plant in Malaysia. These renewals followed standard GMP inspections and were issued by the Health Products Regulatory Authority (HPRA) of Ireland, acting on behalf of the EMA.

One of the company spokesperson said that “These GMP certifications across our manufacturing sites in India and Malaysia reflects Biocon’s continued compliance with the highest standards of quality and our unwavering commitment to addressing patient needs globally.”