EMA Approves Biocon Biologics' New mAbs Facility and Renews GMP Certifications

Biocon Biologics Ltd (BBL), a prominent global player in the biosimilars industry and a subsidiary of Biocon Ltd, has recently achieved a significant milestone. On June 24, 2024, the company received approval from the European Medicines Agency (EMA) to start manufacturing biosimilar Bevacizumab at its state-of-the-art, multi-product monoclonal antibodies (mAbs) drug substance facility located in Bengaluru, India. This approval marks a crucial step forward as it substantially increases the company’s capacity to cater to patient needs across various European markets.

Previously, this modern facility had been granted approval to produce biosimilar Trastuzumab in September 2022. The new authorization to manufacture Bevacizumab, which is used in the treatment of several types of cancers, further enhances the facility's versatility and production capabilities.

In addition to the EMA’s approval for the production of Bevacizumab, Biocon Biologics has also successfully renewed its Good Manufacturing Practice (GMP) Certificates of Compliance for its biosimilars manufacturing site in Bengaluru. Similarly, the company's insulin production plant in Malaysia has also had its GMP certification renewed. These certifications were issued following routine inspections by the Health Products Regulatory Authority (HPRA) of Ireland, acting on behalf of the EMA.

The renewal of these GMP certifications is an endorsement of Biocon Biologics' adherence to stringent quality standards. Achieving and maintaining these certifications is crucial for pharmaceutical companies as they assure that products are consistently produced and controlled to quality standards appropriate for their intended use.

A company spokesperson emphasized the importance of these regulatory milestones, stating that the certifications across their manufacturing sites in India and Malaysia underscore Biocon Biologics' dedication to maintaining the highest quality standards. This commitment is vital as the company continues to focus on addressing the medical needs of patients worldwide.

In summary, Biocon Biologics Ltd has bolstered its manufacturing capabilities with the EMA's approval to produce biosimilar Bevacizumab at its advanced facility in Bengaluru. This development, along with the renewed GMP certifications for its sites in India and Malaysia, highlights the company's ongoing commitment to quality and patient care on a global scale.