Biocon's Bengaluru Facility Gets EMA Nod for Biosimilar Bevacizumab Production

Biocon's Bengaluru facility has received approval from the European Medicines Agency to manufacture biosimilar Bevacizumab. This approval will enhance the facility's capacity to meet patient needs across Europe. The EMA also renewed its Good Manufacturing Practice certificates for facilities in Bengaluru and Malaysia.

Biocon's arm, Biocon Biologics, has secured a crucial approval from the European Medicines Agency (EMA) to manufacture the biosimilar Bevacizumab at its state-of-the-art Bengaluru facility. The green light from EMA significantly expands the facility's capacity to cater to European markets, Biocon announced on Monday.

Bevacizumab, a treatment for colorectal, lung, and ovarian cancers, will now be produced in Bengaluru, which had earlier received approval for manufacturing biosimilar Trastuzumab in September 2022. The EMA's endorsement underscores the facility's compliance with stringent quality standards, as affirmed by the renewal of its Good Manufacturing Practice (GMP) certification.

In addition, the company's insulin facility in Malaysia also reaffirmed its GMP compliance, courtesy of the Health Products Regulatory Authority (HPRA), Ireland. This reinforces Biocon Biologics' steadfast commitment to global patient care. Meanwhile, the US FDA concluded a GMP inspection of Biocon's Visakhapatnam-based API facility, highlighting four observations. As of the latest update, Biocon's shares were slightly down by 0.54% on the BSE.

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