Biocon Biologics receives EMA approval for cancer drug

Biocon Biologics received approval from the European Medicines Agency to manufacture biosimilar Bevacizumab at its new, multi-product monoclonal antibodies drug substance facility in Bengaluru, the drugmaker says in a press statement released today.

Biocon Biologics is an international fully integrated biosimilar subsidiary of listed Biocon Limited. Biocon Biologics offers a portfolio of eight commercialised biosimilars across the globe which include Insulin Glargine, Insulin Aspart, recombinant Human Insulin, Trastuzumab, Bevacizumab, Pegfilgrastim, Adalimumab and Etanercept. The company expects to include 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases.

This approval paves the way for building significant additional capacity to address the growing demands for biologics across patients in the European markets. The facility is designed to produce multiple drug substances and received approval for manufacturing biosimilar Trastuzumab in September 2022.

Earlier in May, the company that acquired Viatris also obtained US FDA approval for its biosimilar Yesafili to enter the US ophthalmology market. The firm had already received approvals from Canada for the same biosimilar in March and has engaged in collaboration with pharmaceutical companies worldwide.

The press release also stated that EMA has renewed its Good Manufacturing Practice Certificates of Compliance for its biosimilar manufacturing facility in Bengaluru and its insulin facility in Malaysia following routine GMP inspections. On behalf of the EMA, Ireland’s Health Products Regulatory Authority (HPRA) issued the GMP certifications.

“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,” stated a company spokesperson.

The EMA approval for the firm’s Bengaluru facility for biosimilar Bevacizumab comes at a time when the biologics market is set for a substantial expansion, with demand expected to grow at a rate of 11.5% annually, according to a report by the Convention on Pharmaceutical Ingredients (CPHI)

Pfizer defines biologics as “medicines that have been developed from naturally occurring systems, including human, animal, or microorganism. Their complexity enables them to be used to treat a variety of conditions for which no other treatments are available.”

Bevacizumab is commonly used in the treatment of various cancers. These include colon, rectal, lung, cervical, and kidney cancer making it a critical therapeutic option for many patients.

The approval of the facility will increase Biocon’s production capacity to enhance the access of its essential medicines to Europe.

The biosimilar Trastuzumab for which the firm already received approval for production is used to treat breast cancer and stomach cancer.

Last week, Biocon announced that the US Food and Drug Administration had issued three observations following a GMP inspection at its active pharmaceutical ingredients (API) manufacturing facility in Visakhapatnam, Andhra Pradesh. Biocon stated that it would provide a timely response to the USFDA.