Sandoz and Formycon Secure Aflibercept Biosimilar Settlement Agreements with Regeneron
核心洞察
Sandoz reached a settlement agreement with Regeneron allowing launch of ENZEEVU (搜索) (aflibercept-abzv) biosimilar in the fourth quarter of 2026.
Formycon (搜索) settled its BPCIA litigation with Regeneron, resulting in dismissal of all claims and vacation of the preliminary injunction against AHZANTIVE (aflibercept-mrbb).
The settlements are part of ongoing multi-district litigation involving multiple biosimilar developers challenging Regeneron's aflibercept patents for neovascular age-related macular degeneration (搜索) treatment.
Two major biosimilar developers have secured settlement agreements with Regeneron Pharmaceuticals in the ongoing aflibercept multi-district litigation, clearing pathways for competitive alternatives to the blockbuster ophthalmology drug used to treat neovascular age-related macular degeneration (搜索).
Sandoz Settlement Enables 2026 Launch
On September 9, 2025, the District Court for the Northern District of West Virginia entered a stipulation and order dismissing all claims and counterclaims between Sandoz and Regeneron regarding the BPCIA litigation for Sandoz's aflibercept biosimilar, ENZEEVU (搜索) (aflibercept-abzv). Under the terms of the settlement agreement, Sandoz will be able to launch ENZEEVU in the fourth quarter of 2026.
The settlement resolves patent disputes surrounding Sandoz's biosimilar version of aflibercept, a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A (搜索)) and placental growth factor (PlGF (搜索)), inhibiting abnormal vessel growth. In patients with neovascular age-related macular degeneration (搜索), aflibercept is injected into the eye to improve visual acuity and inhibit disease progression.
Formycon Achieves Complete Resolution
Formycon (搜索) secured an even more comprehensive settlement on September 29, 2025, when the District Court entered a stipulation and order dismissing without prejudice all claims and defenses asserted by Regeneron against Formycon relating to its 2 mg aflibercept product, AHZANTIVE (aflibercept-mrbb). The court also vacated the preliminary injunction previously entered against Formycon, providing the company with immediate relief from litigation constraints.
The settlement agreement resolved all counterclaims and defenses asserted by Formycon (搜索) against Regeneron in the BPCIA litigation regarding the aflibercept biosimilar.
Broader Multi-District Litigation Landscape
The aflibercept multi-district litigation consists of multiple actions consolidated in the Northern District of West Virginia, with Regeneron filing suit under the Biologics Price Competition and Innovation Act against six biosimilar developers: Amgen, Mylan/Biocon, Celltrion, Formycon (搜索), Samsung (搜索), and Sandoz.
The Federal Circuit has affirmed preliminary injunctions against Celltrion, Samsung (搜索), and Formycon (搜索), while denying the entry of a preliminary injunction against Amgen. Mylan and Biocon settled their BPCIA dispute with Regeneron earlier in 2025, joining the growing list of resolved cases.
Ongoing Legal Challenges
Despite the recent settlements, significant litigation remains active. On September 15, 2025, Celltrion and Regeneron filed a stipulation and briefing schedule concerning Celltrion's forthcoming motion to dissolve the preliminary injunction currently in place against the company. Regeneron confirmed it will oppose the motion, with Celltrion's opening brief due October 31, 2025, Regeneron's opposition brief due November 21, 2025, and Celltrion's reply brief due December 12, 2025.
The stipulation does not indicate the specific basis for Celltrion's request to dissolve the preliminary injunction, leaving the company's legal strategy unclear as the case proceeds through the briefing schedule.