Biocon Biologics, a subsidiary of Biocon, received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab in India. This approval allows Biocon Biologics to produce Bevacizumab at its newly established multi-product monoclonal antibodies (mAbs) drug substance facility located in Bengaluru.

According to a statement from the company, this development significantly enhances their capacity to meet the demand for Bevacizumab across European markets. Previously, the facility had received approval to manufacture biosimilar Trastuzumab in September 2022.

In addition to the manufacturing approval, the facility has also been awarded Good Manufacturing Practice (GMP) Certificates of Compliance by the EMA. These certifications were issued by the Health Products Regulatory Authority (HPRA) of Ireland on behalf of the EMA. Biocon highlighted that similar GMP certifications were granted to its insulin manufacturing facility in Malaysia.

A spokesperson from Biocon Biologics emphasized that these certifications underscore their commitment to maintaining the highest standards of quality and meeting global patient needs. The company remains dedicated to ensuring compliance with regulatory requirements and advancing its capabilities in biologics manufacturing.

The approval to manufacture Bevacizumab in India marks a significant milestone for Biocon Biologics as it expands its footprint in the global biosimilars market, catering to critical healthcare needs worldwide.