Biocon Biologics Ltd on Monday announced that it has received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its new multi-product monoclonal antibodies (mAbs) drug substance facility at Bengaluru.
According to the company’s statement, this approval will provide significant additional capacity to address patients’ needs across markets in Europe. The facility has previously been approved to manufacture biosimilar Trastuzumab in September 2022.
The Company also announced that EMA has renewed its Good Manufacturing Practice (GMP) Certificates 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 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,” a company spokesperson said in a statement.
