On September 9, 2025, the District Court for the Northern District of West Virginia entered a Stipulation and Order dismissing all claims and counterclaims in view of a settlement agreement between Sandoz, Inc. (“Sandoz”) and Regeneron Pharmaceuticals, Inc. (“Regeneron”) resolving the BPCIA litigation regarding Sandoz’s aflibercept biosimilar, ENZEEVU (aflibercept-abzv). According to Sandoz, under the terms of the settlement agreement, they will be able to launch ENZEEVU in the fourth quarter of 2026.
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, the Federal Circuit affirmed preliminary injunctions against Celltrion, Samsung, and Formycon, and denied the entry of a preliminary injunction against Amgen. These cases remain pending. As we also reported, Mylan/Biocon settled their BPCIA dispute with Regeneron earlier this year.