Biocon Biologics gets Canada market entry date for ophthalmic drug Yesafili [Video]

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 …