On February 11, 2026, Samsung Bioepis, Co., Ltd (“Samsung”) and Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Joint Stipulation and Proposed Order seeking to dismiss all claims and counterclaims without prejudice and to vacate the preliminary injunction previously entered against Samsung. According to Regeneron, the parties entered into a settlement agreement that will allow Samsung to launch its aflibercept biosimilar OPUVIZ® (aflibercept-yszy) in the United States in January 2027. The financial and other terms of the agreement are confidential.
Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor A (“VEGF-A”) and placental growth factor (“PlGF”), inhibiting abnormal vessel growth. In patients with neovascular age-related macular degeneration (“nAMD”), aflibercept is injected into the eye to improve visual acuity and inhibit disease progression.
The aflibercept multi-district litigation consisted of multiple actions consolidated in the Northern District of West Virginia, with Regeneron filing suit under the BPCIA against Amgen, Mylan/Biocon, Celltrion, Formycon, Samsung, and Sandoz. As we have previously reported, Mylan/Biocon, Celltrion, Formycon, and Sandoz settled their BPCIA dispute with Regeneron in 2025. As we also reported, the Federal Circuit affirmed the denial of a preliminary injunction against Amgen. This matter is the sole remaining action pending in the aflibercept multi-district litigation.
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