New Delhi, Jun 24 (KNN) In a significant development for the global biosimilars market, Biocon Biologics, a subsidiary of Indian biotechnology giant Biocon, has secured approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its state-of-the-art facility in Bengaluru, India.

The newly approved multi-product monoclonal antibodies (mAbs) drug substance facility is expected to substantially increase the company's capacity to meet growing patient demand across European markets.

This facility had previously received EMA approval for the production of biosimilar Trastuzumab in September 2022, further solidifying Biocon Biologics' position as a key player in the biosimilars space.

In addition to the manufacturing approval, the EMA has renewed Good Manufacturing Practice (GMP) Certificates of Compliance for Biocon Biologics' biosimilars manufacturing facility in Bengaluru and its insulin facility in Malaysia.

These certifications were issued following routine GMP inspections conducted by the Health Products Regulatory Authority (HPRA) of Ireland, acting on behalf of the EMA.

A company spokesperson emphasised the significance of these developments, stating, "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."

The approval for biosimilar Bevacizumab production and the renewed GMP certifications underscore Biocon Biologics' growing importance in the global pharmaceutical supply chain.

As biosimilars continue to gain traction as cost-effective alternatives to original biologics, this expansion of manufacturing capabilities is likely to have far-reaching implications for patient access to critical medications in Europe and beyond.

Industry analysts predict that this move will not only strengthen Biocon Biologics' market position but also contribute to the broader trend of increasing biosimilar adoption in European healthcare systems.

The company's ability to manufacture multiple biosimilars at a single facility showcases the advancements in biopharmaceutical manufacturing technology and the increasing sophistication of emerging market players in the global pharma landscape.

As the biosimilars market continues to evolve, developments such as this are expected to play a crucial role in shaping the future of affordable and accessible biologic treatments for patients worldwide.

(KNN Bureau)