EMA approves Biocon Biologics' new monoclonal antibodies facility, renews GMP certifications for India and Malaysia sites
Jun 24, 2024
Bengaluru (Karnataka) [India], June 24 : Biocon Biologics Ltd (BBL), a global leader in biosimilars and a subsidiary of Biocon Ltd, announced on Monday that it has received European Medicines Agency (EMA) approval for its state-of-the-art monoclonal antibodies (mAbs) manufacturing facility in Bengaluru, India.
According to a press release, this facility, designed to produce multiple drug substances, will now commence the production of biosimilar Bevacizumab, enhancing the company's capacity to meet the growing demand for biologics across European markets.
This EMA approval is a significant milestone for Biocon Biologics, as it underscores the company's commitment to delivering high-quality biologics on a global scale.
The newly approved facility in Bengaluru had previously received EMA clearance in September 2022 to manufacture biosimilar Trastuzumab, further establishing its role as a key player in the biosimilars market.
In addition to the new facility approval, Biocon Biologics also announced that the EMA has renewed its Good Manufacturing Practice (GMP) Certificates of Compliance for its biosimilars manufacturing site in Bengaluru and its insulin manufacturing facility in Malaysia.
These certificates, issued by the Health Products Regulatory Authority (HPRA) of Ireland on behalf of the EMA, affirm the company's adherence to the highest standards of manufacturing quality and regulatory compliance.
"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," said a company spokesperson.
The EMA approval of the Bengaluru facility for biosimilar Bevacizumab comes at a crucial time when the demand for affordable and effective biologics is on the rise.
Bevacizumab, commonly used in the treatment of various cancers, including colorectal, lung, and kidney cancer, is a critical therapeutic option for many patients.
The addition of this manufacturing capability will enable Biocon Biologics to significantly increase its production capacity, thereby improving access to essential medicines across Europe and beyond.
