Medicines and Healthcare products Regulatory Agency (MHRA) issues UK marketing approval for Biocon Biologics biosimilar aflibercept (YESAFILI)

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Biocon Ltd announced its subsidiary Biocon Biologics Limited received marketing authorization approval from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its product YESAFILI. According to a press release from Biocon, YESAFILI is a biosimilar with comparable efficacy, safety and quality to the reference product Eylea (aflibercept).¹

Earlier this year, YESAFILI underwent the approval process in the European Union. The biosimilar received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in July and received a marketing authorization from the European Commission in September.

Biocon’s YESAFILI is intended for treatment of a number of ocular conditions, including neovascular age-related macular degeneration, visual impairment due to myopic choroidal neovascularisation, visual impairment due to diabetic macular edema and visual impairment due to macular edema secondary to retinal vein occlusion.

In the news release, Biocon expressed that the biosimilar approval will help the company expand its product portfolios in ophthalmology, diabetes care and oncology.

In July, Shreehas Tambe, CEO and managing director of Biocon Biologics, commented on the positive CHMP opinion for YESAFILI.2 "This is further confirmation of our strong commitment to providing high-quality and affordable medicines and represents another significant milestone as we continue to expand our biosimilar offerings across the globe,” Tambe said.

References:

1. Biocon Biologics Receives MHRA, UK Approval for YESAFILI®, Biosimilar Aflibercept. News release. Biocon Ltd. 13 November, 2023. https://www.biocon.com/biocon-biologics-receives-mhra-uk-approval-for-yesafili-biosimilar-aflibercept/

2. Hayes, H. European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issues positive opinion for aflibercept biosimilar YESAFILI®. Ophthalmology Times Europe. 25 July, 2023. Accessed 13 November, 2023. https://europe.ophthalmologytimes.com/view/chmp-european-positive-opinion-aflibercept-biosimilar-yesafili