On December 3, 2025, Fresenius Kabi and SamChunDang Pharm announced the FDA acceptance of their aBLA for SCD-411 (aflibercept), a proposed biosimilar of Regeneron’s EYLEA® (aflibercept). Under their licensing agreement SamChunDang developed the biosimilar candidate and Fresenius Kabi will exclusively commercialize it in the U.S. Fresenius Kabi and SamChunDang have challenged Regeneron’s U.S. Patent Nos. 11,084,865 (IPR2025-01268) and 10,828,345 (IPR2025-01269) (previously reported Fresenius Kabi Files Two EYLEA® IPRs Prior to aBLA Filing Announcement). The IPRs are awaiting institution decisions.
On December 19, 2025, Alvotech and Teva announced a settlement agreement with Regeneron relating to AVT06 (aflibercept), their proposed EYLEA® biosimilar. The agreement allows for the launch of AVT06 in the fourth quarter of 2026, or earlier under certain undisclosed circumstances, subject to FDA approval. Alvotech has challenged Regeneron’s U.S. Patent No. 12,168,036 in PGR2025-00085. This PGR remains pending and is awaiting an institution decision.
Regeneron has settled lawsuits with numerous other biosimilar applicants and provided market entry dates in 2026, including Yesafili™ (aflibercept-jbvf) in the second half of 2026 (previously reported Regeneron and Biocon Settle Litigation over EYLEA® Biosimilar Yesafili™), Enzeevu™ (aflibercept-abzv) and Ahzantive® (aflibercept-mrbb) in the fourth quarter of 2026 (previously reported Regeneron Settles Litigations with Sandoz and Formycon over EYLEA® Biosimilars Enzeevu™ and Ahzantive®), and Eydenzelt® (aflibercept-boav) as early as December 31, 2026 (previously reported Regeneron Settles Litigations with Celltrion over EYLEA® Biosimilar Eydenzelt®).
SCD-411 and AVT06 are the only publicly announced aBLAs for EYLEA® biosimilars currently pending with the FDA. To date, the FDA has approved six EYLEA® biosimilars and one, Pavblu™ (aflibercept-ayyh), has launched at-risk (previously reported Amgen Launches Pavblu™ as the First EYLEA® Biosimilar in the U.S.).
Regeneron reported EYLEA® U.S. sales of $4.77 billion in FY2024.
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The author would like to thank April Breyer Menon for her contributions to this article.
