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Biocon Biologics gets positive opinion from EMA for ophthalmology product

Yesafili aims to treat various visual impairments and age-related macular degeneration

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Biocon

Anjali Singh Mumbai

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Biocon Biologics, a subsidiary of Biocon, on Monday announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion recommending the approval of Yesafili, an aflibercept biosimilar. The commission’s final decision is expected in September, analysts said. 

Yesafili has been developed as an ophthalmology product and aims to provide treatment for various visual impairments and age-related macular degeneration. 

Calling it an encouraging development, Kunal Randeria, analyst with Nuvama Research, said Biocon had become the first player to get a positive opinion from CHMP. “This is likely to be a hotly contested space given the competitive intensity comprising Amgen, Alvotech, Samsung, Sandoz and Formycon,” he said. “Given that the launch is likely to be only in FY26 (active ingredient expires in 2025 in EU countries), this could see multiple players in the first wave. EU market size (for Aflibercept) is $1.8 billion, as per IQVIA (a market research body)," he added.

Reacting to the development, Biocon Biologics CEO and Managing Director Shreehas Tambe said, “We look forward to making a meaningful difference to patients in the EU impacted by macular degeneration and diabetic retinopathy through Yesafili.”

Biocon Biologics also said that data has shown that Yesafili had exhibited comparable quality, safety and efficacy to its reference product, Eylea (aflibercept). The validation from the CHMP paves the way for the biosimilar to be considered for approval by the European Commission, with the decision expected by the end of September 2023.

Aflibercept biosimilar is intended to treat neovascular age-related macular degeneration and other visual impairment issues. Age-related macular degeneration is an eye disease that can blur one's central vision. It happens when aging causes damage to the macula, the part of the eye that controls sharp, straight-ahead vision.

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First Published: Jul 24 2023 | 1:58 PM IST

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