Biocon announced on Monday that its unit, Biocon Biologics, has been granted approval by the European Medicines Agency (EMA) to produce biosimilar Bevacizumab at its new facility in Bengaluru. The approval will significantly increase the company’s capacity to meet the needs of patients in European markets, according to a company statement. Bevacizumab is used to treat health conditions such as colorectal cancer, lung cancer, and ovarian cancer.
The Bengaluru facility had previously received approval to manufacture biosimilar Trastuzumab in September 2022. In addition, Biocon stated that the EMA has renewed its Good Manufacturing Practice (GMP) certificate of compliance for its biosimilar manufacturing facility in Bengaluru and its insulin facility in Malaysia, following routine GMP inspections. These certificates were issued by the Health Products Regulatory Authority (HPRA), Ireland, on behalf of EMA.
A spokesperson for the company stated, “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.”
Last week, Biocon informed the stock exchanges that the US health regulator had issued four observations after inspecting its manufacturing plant in Andhra Pradesh. The US Food and Drug Administration (USFDA) concluded a GMP inspection of the company’s API facility (Site 5) located in Visakhapatnam, Andhra Pradesh, on June 21, 2024.
Biocon’s shares were trading 0.54 per cent down at Rs 343.75 apiece on the BSE.
