On August 3, 2026, Biocon announced the launch of Yesafili™ (aflibercept-jbvf), an interchangeable biosimilar of Regeneron’s EYLEA^® (aflibercept), after FDA-approval in May 2024.  Yesafili™ was initially under a permanent injunction after numerous claims of Regeneron’s U.S. Patent No. 11,084,865 were found valid and infringed in BPCIA litigation No. 1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) (previously reported Permanent Injunction Issued Preventing Launch of EYLEA^® Biosimilar Yesafili™).  Biocon and Regeneron later settled the litigation and requested that the permanent injunction be vacated (previously reported Regeneron and Biocon Settle Litigation over EYLEA^® Biosimilar Yesafili™).

Yesafili™ is the second EYLEA^® biosimilar to launch in the U.S. and the first to launch under a settlement agreement.  Amgen launched Pavblu^® (aflibercept-ayyh) at-risk in October 2024 after a preliminary injunction was denied, and litigation is still ongoing (Case Nos. 1:24-cv-00039 (N.D.W. Va.) / 1:25-cv-00074 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.)) (previously reported Amgen Launches Pavblu™ as the First EYLEA^® Biosimilar in the U.S.).

On August 6, 2026, the USPTO Director denied institution for discretionary reasons of Biocon’s PGR2026-00039, challenging Regeneron’s U.S. Patent No. 12,168,036.  Biocon had requested joinder with Alvotech’s PGR2025-00085, which was instituted in March 2026.  While the denial was issued as part of a bulk order, the Director noted that an opinion is forthcoming.

Regeneron reported EYLEA^® U.S. sales of $2.75 billion and EYLEA^® HD U.S. sales of $1.64 billion in FY2025.

For more information about these and other biosimilars, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contributions to this article.