Biocon Biologics receives MHRA approval for Biosimilar, Yesafili

Biocon, the biotechnology firm based in Bengaluru, announced on Monday that its subsidiary, Biocon Biologics, has secured marketing authorization for its biosimilar product, Yesafili, from the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

Yesafili, designed as an ophthalmology product, is specifically intended for the treatment of neovascular (wet AMD) age-related macular degeneration, among other related issues. The biosimilar shares a high similarity with the reference product Eylea (aflibercept).

In a regulatory filing, the company expressed its commitment to expanding its biosimilar offerings globally, leveraging the approval from MHRA. Yesafili's approval adds to Biocon's existing portfolios in oncology and diabetes.

A spokesperson for Biocon stated, "This approval will expand our biosimilar offerings to patients across the globe, building on our oncology and diabetes product portfolios."

According to IQVIA sales data, Aflibercept brand sales in the UK reached USD 790 million, indicating a significant market potential for Yesafili. The biosimilar's approval marks a milestone for Biocon as it strengthens its position in the global biosimilars market.