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EMA Approves New Monoclonal Antibodies Facility for Biocon Biologics in India; Renews GMP Certifications for Sites in India and Malaysia

NextEdge Admin

24 Jun 2024

1 min 17 sec

Biocon Biologics, a subsidiary of Biocon, has received approval from the European Medicines Agency (EMA) to produce biosimilar Bevacizumab at its newly established, state-of-the-art facility for monoclonal antibodies (mAbs) in Bengaluru. This approval is expected to significantly enhance capacity to meet patient demands across European markets.

Additionally, the company announced that the EMA has renewed its Good Manufacturing Practice (GMP) Certificates of Compliance for its biosimilars manufacturing facility in Bengaluru and its insulin facility in Malaysia, following regular GMP inspections conducted by the Health Products Regulatory Authority (HPRA) of Ireland on behalf of the EMA.

"This reaffirmation of GMP certifications at our sites in India and Malaysia underscores Biocon Biologics' steadfast adherence to the highest quality standards and our enduring commitment to global patient care," stated a company spokesperson.