ARTICLE
15 March 2024

Biocon Settles With Bayer And Regeneron, Securing Canada Market Entry Date For Aflibercept Biosimilar

GP
Goodwin Procter LLP
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On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon's proposed biosimilar to EYLEA.
United States Food, Drugs, Healthcare, Life Sciences
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On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon's proposed biosimilar to EYLEA (aflibercept). The settlement resolves multiple patent infringement proceedings in the Federal Court of Canada. Under the agreement, Biocon can launch YESAFILI in Canada no later than July 1, 2025. In March 2023, Health Canada granted tentative approval for YESAFILI 2 mg vials, subject to resolution of any patent disputes. Extensive cover of U.S. patent litigation related to biosimilars of EYLEA (aflibercept) can be found on the Big Molecule Watch's BPCIA Litigation Tracker.

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ARTICLE
15 March 2024

Biocon Settles With Bayer And Regeneron, Securing Canada Market Entry Date For Aflibercept Biosimilar

United States Food, Drugs, Healthcare, Life Sciences
Contributor
At Goodwin, we partner with our clients to practice law with integrity, ingenuity, agility, and ambition. Our 1,600 lawyers across the United States, Europe, and Asia excel at complex transactions, high-stakes litigation and world-class advisory services in the technology, life sciences, real estate, private equity, and financial industries. Our unique combination of deep experience serving both the innovators and investors in a rapidly changing, technology-driven economy sets us apart.
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