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ARTICLE · 11 JUNE 2024

Updates On Aflibercept Biosimilar Approvals And BPCIA Litigation

Goodwin Procter LLP
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Regeneron's regulatory exclusivity for EYLEA expired on May 18, 2024. Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals...

United StatesIntellectual Property
Grace Peace Truong
Grace Peace Truong

FDA approves first interchangeable biosimilars to EYLEA (aflibercept) to treat macular degeneration and other eye conditions

Regeneron's regulatory exclusivity for EYLEA expired on May 18, 2024. Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals, Inc. and Biocon Biologics, Inc.'s YESAFILI (aflibercept-jbvf) and Samsung Bioepis, Co., Ltd.'s OPUVIZ (aflibercept-yszy) as interchangeable biosimilars to Regeneron Pharmaceutical, Inc.'s EYLEA (aflibercept). These are the first biosimilar aflibercept products approved by the FDA.

According to the announcement, YESAFILI and OPUVIZ are used to treat neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. Both YESAFILI and OPUVIZ are administered intravitreally (in the eye) as a 2 mg (0.05 mL of 40 mg/mL) injectable solution to treat patients for the aforementioned conditions according to

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