EMA approves Biocon Biologics’ new mAbs facility in India

New Delhi: Biocon Biologics has received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its new state-of-the-art, multi-product monoclonal antibodies (mAbs) drug substance facility in Bengaluru.

This approval will provide significant additional capacity to meet the needs of patients across Europe. Previously, the facility was approved to manufacture biosimilar Trastuzumab in September 2022.

In addition to the new facility’s approval, EMA has renewed the Good Manufacturing Practice (GMP) Certificates of Compliance for Biocon Biologics’ biosimilars manufacturing facility in Bengaluru and its insulin facility in Malaysia. These certifications follow routine GMP inspections and were issued by the Health Products Regulatory Authority (HPRA) of Ireland on behalf of EMA.

“These GMP certifications across our manufacturing sites in India and Malaysia reflect Biocon Biologics’ continued compliance with the highest standards of quality and our unwavering commitment to addressing patient needs globally,” stated a company spokesperson.