INDIA—Biocon Biologics Ltd., a subsidiary of Biocon Ltd. and a globally integrated biosimilars company, has announced that it has reached an agreement with Bayer Inc. and Regeneron Pharmaceuticals.
This agreement allows Yesafili, a potential biosimilar of EYLEA (aflibercept) injection, to be introduced into the Canadian market, according to the company’s exchange filing.
According to the announcement, Biocon Biologics has obtained a launch date for Yesafili 2 mg NDS for vials and prefilled syringes (to be filed) no later than July 1, 2025 under the conditions of the agreement.
The announcement also stated that Health Canada had tentatively approved Yesafili 2 mg vials in March 2023, subject to patent obstacles being resolved.
The settlement resolves multiple parallel patent infringement proceedings in the Federal Court of Canada involving six patents, as well as associated judicial review proceedings, under Canada’s Patented Medicines (Notice of Compliance) Regulations, which address pre-entry pharmaceutical patent litigation, according to stock exchanges.
Yesafili is intended to treat a variety of ophthalmic conditions, including neovascular age-related macular degeneration (wet AMD), visual impairment caused by macular oedema caused by retinal vein occlusion (branch RVO or central RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (CNV).
The biosimilar’s potency stems from its strong similarities to the reference medicine Eylea (aflibercept), a well-established medication in the field.
A thorough data study shows that Yesafili is of equivalent quality, safety, and efficacy to Eylea.
The Medicines and Healthcare Products Regulatory Agency of the United Kingdom approved Biocon Biologics’ marketing authorization for Yesafili in November 2023.
The company then stated that with aflibercept brand sales in the UK exceeding US$790 million, the approval of Yesafili opens up additional opportunities for Biocon Biologics.
Biocon Biologics has the registered trademark “Yesafili.”
Following the announcement, Biocon Biologics’ shares have opened nearly half a percent higher on the Bombay Stock Exchange (BSE) at Rs 278.10 (US$3.36).
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