EMA Approves Biocon Biologics' New mAbs Facility in India, Renews GMP Certifications
Biocon Biologics Ltd (BBL) 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.
Key Highlights
- EMA approves Biocon Biologics' new mAbs facility in India for biosimilar Bevacizumab manufacturing.
- The new facility will provide significant additional capacity to address patients’ needs across markets in Europe.
- Biocon Biologics' Bengaluru facility was previously approved for biosimilar Trastuzumab manufacturing in September 2022.
- EMA renews GMP Certificates of Compliance for Biocon Biologics' biosimilars manufacturing facility in Bengaluru and insulin facility in Malaysia.
- The GMP certifications reflect Biocon Biologics' commitment to quality and patient needs globally.