Biocon Biologics shall launch its ophthalmic drug Yesafili in Canada no later than July 1, 2025, the subsidiary of biotechnology major Biocon said on March 4.
“Biocon Biologics Ltd, a globally integrated biosimilars company and a subsidiary of Biocon Ltd, has announced the signing of a settlement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. This agreement paves the way for the introduction of Yesafili, a proposed biosimilar to EYLEA® (aflibercept) Injection, into the Canadian market,” the company said in an exchange filing.
According to the statement, under the terms of the agreement, Biocon Biologics has secured a launch date for Yesafili 2 mg NDS for vials and prefilled syringes (yet to be filed), set no later than July 1, 2025. It added that Health Canada had granted tentative approval for Yesafili 2 mg vials, subject to resolution of any patent issues, in March 2023.
The settlement resolves multiple parallel patent infringement proceedings in the Federal Court of Canada involving six patents, and associated judicial review proceedings, under Canada’s Patented Medicines (Notice of Compliance) Regulations addressing pre-entry pharmaceutical patent litigation, they told the stock exchanges.
The drug Yesafili is designed to address a spectrum of ophthalmic conditions, including neovascular age-related macular degeneration (wet AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), diabetic macular edema (DME), and myopic choroidal neovascularisation (myopic CNV).
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The biosimilar's potency lies in its striking similarity to the reference product Eylea (aflibercept), a well-established treatment in the field. Rigorous data analysis underscores that Yesafili demonstrates comparable quality, safety, and efficacy to Eylea.
In November 2023, Biocon Biologics received marketing authorisation approval from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency for Yesafili.
The firm had then said that with aflibercept brand sales in the UK reaching $790 million, the approval of Yesafili opens up new avenues for Biocon Biologics. Yesafili is a registered trademark of Biocon Biologics.
Following the announcement, Biocon Biologics shares opened almost half a percent higher at Rs 278.10 on BSE.
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