Biocon, Regeneron settle to launch aflibercept biosimilar, Yesafili in the US

Biocon Biologics announced it has reached a settlement and license agreement with Regeneron to commercialize aflibercept-jbvf (Yesafili), an interchangeable biosimilar to aflibercept, in the US.

Biocon and Regeneron executed the settlement agreement to dismiss the pending appeal at the United States Court of Appeals for the Federal Circuit (USCAFC) of patent US11084865 and the pending litigation at the US District Court for the Northern District of West Virginia, Clarksburg Division.

According to the company, this agreement allows it to launch in the US in the second half of 2026 or earlier in certain circumstances. Terms of the settlement are confidential the company added.

Shreehas Tambe, CEO & managing director at Biocon Biologics, commented on the settlement in a press release from the company.

“This settlement clears the path for Biocon Biologics to be among the first to bring a reliable, high-quality aflibercept biosimilar to patients and healthcare providers in the United States. As the first-to-file interchangeable biosimilar to Eylea, Yesafili affirms our scientific strength and marks our strategic entry into Ophthalmology, expanding our footprint in the US and advancing our mission to increase access to life-changing treatments,” said Tambe.

The US Food and Drug Administration (FDA) previously approved the biosimilar from Biocon in May 2024. Biocon also previously secured a settlement agreement in Canada with Bayer and Regeneron for the launch of Yesafili. The launch will occur no later than July 1, 2025.

Yesafili is intended for the treatment of neovascular age-related macular degeneration (AMD), visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular edema (DME), and visual impairment due to myopic choroidal neovascularization (myopic CNV).

References:

1. Biocon Biologics secures market entry date for Yesafili, an interchangeable biosimilar to Eylea, in the US. Published April 14, 2025. Accessed April 15, 2025. https://www.prnewswire.com/news-releases/us-fda-grants-interchangeable-designation-to-yuflyma-adalimumab-aaty-celltrions-biosimilar-to-humira-adalimumab-302428226.html?tc=eml_cleartime