Biocon Biologics, a biopharmaceutical company, has reached a settlement and license agreement with Regeneron to commercialize its aflibercept-jbvf (Yesafili) biosimilar, an interchangeable version of Regeneron’s aflibercept, in the United States. The agreement dismisses pending patent and litigation claims in the US District Court for the Northern District of West Virginia and the US Court of Appeals for the Federal Circuit. This move clears the path for Biocon Biologics to launch Yesafili in the US, with a potential launch date of the second half of 2026 or earlier if certain circumstances arise. The terms of the agreement are confidential.
Yesafili is intended for the treatment of various eye diseases, including neovascular age-related macular degeneration, retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization. The US Food and Drug Administration (FDA) approved the biosimilar in May 2024, making Biocon Biologics the first to file an interchangeable biosimilar to Eylea, Regeneron’s market-leading treatment for these conditions. This agreement marks Biocon Biologics’ strategic entry into the ophthalmology market in the US, expanding its footprint and furthering its goal to increase access to life-changing treatments.
Biocon Biologics has already secured a settlement agreement in Canada with Bayer and Regeneron for the launch of Yesafili, with a planned launch date of no later than July 1, 2025. The company’s CEO and managing director, Shreehas Tambe, commented on the settlement, stating that it paves the way for Biocon Biologics to bring a reliable and high-quality aflibercept biosimilar to patients in the US. This agreement is a significant milestone for Biocon Biologics, as it represents the company’s first launch in the US ophthalmology market and a key step in its mission to increase access to life-changing treatments.
This settlement is a testament to Biocon Biologics’ scientific expertise and its ability to navigate complex patent and litigation disputes. The company is poised to become one of the first to market a biosimilar in the US, providing patients with a more affordable and accessible treatment option. As Biocon Biologics looks to expand its reach in the US market, this agreement is a significant step forward, demonstrating the company’s commitment to delivering innovative and life-changing treatments to patients.