EMA approves Biocon’s new mAbs facility in India

Biocon Biologics a subsidiary of Biocon, has received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its new, multi-product monoclonal antibodies (mAbs) drug substance facility at Bengaluru. The facility was previously 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 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. 

“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.” – Company Spokesperson