Biocon Biologics on Friday announced that its multi-product, monoclonal antibodies (mAbs) Drug Substance manufacturing facility (B3) at Biocon Park, Bengaluru, has received a Certificate of GMP Compliance for an additional product, biosimilar Bevacizumab, from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
The biosimilar is a medication used to treat a number of types of cancers and specific eye diseases.
“This approval reflects Biocon Biologics’ compliance with the highest international regulatory standards and enables the Company to continue addressing the needs of patients in the EU through its high-quality products. This (B3) facility, which is one of India’s largest monoclonal antibodies (mAbs) manufacturing facilities, had received the EU GMP Certification for manufacturing biosimilar Trastuzumab last year. It was also awarded the ‘Facility of the Year Award’ (FOYA) with an ‘Honourable Mention’, by the International Society for Pharmaceutical Engineering (ISPE) in 2021,” a Company Spokesperson said in a statement.
Last year, the same facility was approved for biosimilar Trastuzumab which is a targeted cancer drug and is also known by other names such as Herceptin, Herzuma, and Ontruzant.
