Biocon Biologics Gets Europe Agency's Nod To Produce Cancer Medicine
The approval will significantly expand its capacity to meet patient demands throughout European markets, the company said.
Biocon Biologics Ltd., a subsidiary of Biocon Ltd., has obtained approval for production of the biosimilar, Bevacizumab, at its new Bengaluru facility from the European Medicines Agency.
The approval will significantly expand its capacity to meet patient demands throughout European markets, an exchange filing said on Monday.
Bevacizumab is used to treat colorectal cancer, lung cancer, and ovarian cancer.
The Bengaluru facility had received approval to manufacture biosimilar Trastuzumab in September 2022.
Biocon's Good Manufacturing Practice certificate was also renewed by the EMA for the biosimilar facility in Bengaluru and the insulin production facility in Malaysia, following standard GMP inspections.
These certificates were issued by the Health Products Regulatory Authority, Ireland, on behalf of EMA, it 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," a company spokesperson said.
Recently, Biocon notified the stock exchanges that the US health regulator issued four observations following the inspection of its manufacturing facility located in Andhra Pradesh.
The US Food and Drug Administration completed a Good Manufacturing Practice inspection of the company's Active Pharmaceutical Ingredients facility in Visakhapatnam, Andhra Pradesh, on June 21.
Shares of Biocon were trading 1.01% lower at Rs 342.20 apiece, as compared with a 0.16% advance in the NSE Nifty 50.
