BRIEF—Biocon's new MAbs facility gains EU GMP certification for bBevacizumab

Indian firm Biocon Biologics’ integrated, multi-product, monoclonal antibodies (MAbs) drug substance manufacturing facility (B3) at Biocon Park, Bengaluru, has received a certificate of Good Manufacturing Practices (GMP) Compliance for an additional product, biosimilar bevacizumab, from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.

Co-developed by Biocon Biologics and Viatris, and given the trade name Abevmy ins some markets, is a biosimilar to Swiss pharma giant Roche’s (ROG: SIX) cancer drug Avastin (bevacizumab).

“This approval reflects Biocon Biologics’ compliance with the highest international regulatory standards and enables the company to continue addressing the needs of patients in the EU through its high-quality products,” noted a company representative.

“This (B3) facility, which is one of India’s largest monoclonal antibodies (mAbs) manufacturing facilities, had received the EU GMP Certification for manufacturing biosimilar trastuzumab last year. It was also awarded the ‘Facility of the Year Award’ (FOYA) with an ‘Honorable Mention,’ by the International Society for Pharmaceutical Engineering (ISPE) in 2021.”