Biocon Biologics Bags EMA Nod to Manufacture Biosimilar Bevacizumab

The European Medicines Agency (EMA) granted permission to Biocon Biologics, a leading global biosimilar player, to manufacture the biosimilar Bevacizumab at its new Bengaluru facility, the company stated. This endorsement will give critical extra ability to address patients' requirements across European business sectors, the organization said in an explanation.
  
Bevacizumab is utilized to deal with ailments like colorectal cancer, lung cancer, and ovarian cancer. In the past, the Bengaluru facility was given permission to produce the biosimilar Trastuzumab in September 2022.

Following routine GMP inspections, Biocon stated that EMA has also renewed its Good Manufacturing Practice (GMP) certificate of compliance for its Bengaluru biosimilar manufacturing facility and Malaysia insulin manufacturing facility. It stated that the Health Products Regulatory Authority (HPRA) of Ireland issued these certificates on EMA's behalf.

"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.

After inspecting its manufacturing plant in Andhra Pradesh, Biocon informed the bourses last week that the US health regulator had made four observations. The US Food and Medication Organization (USFDA) finished up a GMP inspection of the organization's API facility (Site 5), situated at Visakhapatnam, Andhra Pradesh, on June 21, 2024.