Biocon Biologics gets EMA nod to produce biosimilar Bevacizumab at Bengaluru plant
The Bengaluru facility has previously been approved to manufacture biosimilar Trastuzumab in September 2022.
Biocon on Monday said its unit Biologics has received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its new facility at Bengaluru.
This approval will provide significant additional capacity to address patients' needs across markets in Europe, the company said in a statement.
Bevacizumab is used to treat health conditions like colorectal cancer, lung cancer, and ovarian cancer.
The Bengaluru facility has previously been approved to manufacture biosimilar Trastuzumab in September 2022.
Biocon said that EMA has also 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, it said.
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"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.
Last week, Biocon had informed the bourses that the US health regulator has issued four observations after inspecting its Andhra Pradesh-based manufacturing plant.
The US Food and Drug Administration (USFDA) concluded a GMP inspection of the company's API facility (Site 5), located at Visakhapatnam, Andhra Pradesh, on June 21, 2024.
Shares of Biocon were trading 0.54% down at Rs 343.75 apiece on the BSE.
Edited by Megha Reddy