Biocon Ltd’s Subsidiary Receives EMA Approval for Bevacizumab Manufacturing in Bengaluru

On June 24, 2024, Biocon Ltd informed in a stock exchange filing that the company’s subsidiary, Biocon Biologics Ltd (BBL), has obtained approval from the European Medicines Agency (EMA) to commence manufacturing biosimilar Bevacizumab at its newly established monoclonal antibodies (mAbs) drug substance facility in Bengaluru.

This approval marks a significant milestone, enhancing BBL’s capacity to meet the growing demand for biosimilars in European markets. The facility, which previously received approval for biosimilar Trastuzumab production in September 2022, is now expanding its capabilities to include Bevacizumab, addressing critical patient needs.

Additionally, Biocon Ltd announced the renewal of Good Manufacturing Practice (GMP) Certificates of Compliance by EMA for its biosimilar manufacturing unit in Bengaluru and its insulin manufacturing facility in Malaysia. These certificates were reissued following routine GMP inspections conducted by the Health Products Regulatory Authority (HPRA) of Ireland on behalf of EMA. The renewal underscores Biocon’s commitment to maintaining high-quality standards across its manufacturing operations, ensuring adherence to stringent regulatory requirements.

The approval to manufacture Bevacizumab at the Bengaluru facility reinforces Biocon Biologics’ position as a key player in the global biosimilar market, particularly in Europe, where demand for affordable biologic therapies is substantial. This expansion aligns with Biocon’s strategy to leverage its state-of-the-art infrastructure and expertise in biotechnology to deliver innovative and cost-effective treatments to patients worldwide.

With the renewed GMP certificates, Biocon affirms its dedication to sustaining operational excellence and regulatory compliance across its facilities. These certifications are crucial for maintaining product quality and safety and bolstering confidence among healthcare providers and patients relying on Biocon’s biologic and insulin products for critical medical treatments.

Commenting on these significant developments, the company spokesperson said, “These GMP certifications across our manufacturing sites in India and Malaysia reflect Biocon Biologics’ continued compliance with the highest standards of quality and our unwavering commitment to addressing patient needs globally.”

About Biocon Ltd

Biocon is a leading biopharmaceutical company with a global presence, impacting patients in more than 120 countries through innovative and cost-effective treatments for diabetes, cancer, and autoimmune diseases. The company operates across four key global segments: biosimilars, generics, novel biologics and research services.

On June 24, 2024, the share price of Biocon Ltd opened at ₹345.40, touching the day’s low at ₹337.00, as of 11:49 AM on the NSE.

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