On February 18, 2025, Alvotech and Teva announced the FDA acceptance of an aBLA for AVT06 (aflibercept), a proposed biosimilar of Regeneron’s EYLEA® (aflibercept). This aBLA joins Celltrion’s CT-P42 (aflibercept) awaiting FDA-approval. Alvotech and Teva are also developing AVT29 as a biosimilar to Regeneron’s EYLEA® HD (aflibercept), a higher dose (8 mg) version of EYLEA® (2 mg). The FDA has already approved five aflibercept biosimilars, including Biocon / Mylan’s Yesafili™ (aflibercept-jbvf), Samsung Bioepis’s Opuviz™ (aflibercept-yszy), Formycon’s Ahzantive® (aflibercept-mrbb), Sandoz’s Enzeevu™ (aflibercept-abzv), and Amgen’s Pavblu™ (aflibercept-ayyh).
In November 2024, Amgen launched Pavblu™ at-risk as the first EYLEA® biosimilar in the U.S. (previously reported Amgen Launches Pavblu™ as the First EYLEA® Biosimilar in the U.S.). Numerous other EYLEA® biosimilars have had their launches delayed by preliminary injunctions, including Opuviz™, Ahzantive®, and CT-P42 (previously reported Preliminary Injunctions Issued Preventing Launch of EYLEA® Biosimilars). Yesafili™ has been permanently enjoined from launching prior to the expiration of Regeneron’s U.S. Patent No. 11,084,865 (previously reported Permanent Injunction Issued Preventing Launch of EYLEA® Biosimilar Yesafili™).
There are currently eight ongoing litigations and related appeals for EYLEA® biosimilars. There have not been any patent disputes related to AVT06 to date.
Regeneron reported EYLEA® U.S. sales of $4.767 billion in FY2024.
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The author would like to thank April Breyer Menon for her contributions to this article.
