On April 22, 2025, the U.S. District Court for the Northern District of West Virginia entered a Stipulation and Order Vacating Permanent Injunction and Dismissing All Claims and Counterclaims with Prejudice in In re: Aflibercept Patent Litigation (MDL No.: 1:24-md-3103). The stipulation had been filed the day before by Plaintiff Regeneron Pharmaceuticals, Inc. and Defendants Mylan Pharmaceuticals, Inc. and Biocon Biologics, Inc. (“the Parties”), and it sought to have certain prior judgments and orders vacated and dismissed with prejudice. As the Stipulation and Order explained, the court had entered a permanent injunction and final judgment in June 2024, and Defendants had appealed the court’s orders to the Federal Circuit. On April 16, 2025, that appeal was dismissed pursuant to the Parties’ joint stipulation of dismissal filed on April 14, 2025. As explained by the Parties in the Stipulation and Order, they have “reached an agreement that will resolve all issues between them without further litigation.” Accordingly, the court’s permanent injunction and final judgment were vacated, and all claims or counterclaims between the Parties are dismissed with prejudice.
The aflibercept multi-district litigation consists 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. While Mylan/Biocon has settled its dispute with Regeneron, as we have previously reported, the Federal Circuit recently affirmed preliminary injunctions against Celltrion, Samsung, and Formycon, and denied the entry of a preliminary injunction against Amgen. Amgen has since launched PAVBLUTM (aflibercept-ayyh) in the United States. The other biosimilar developers have not yet indicated whether they will appeal the Federal Circuit’s decisions. Thus far, the FDA has approved five aflibercept biosimilars, with Amgen’s PAVBLU™ being the most recent.
According to Biocon, the settlement agreement enables Biocon to launch YESAFILI™ (aflibercept-jbvf) in the United States in the second half of 2026 or earlier, and the terms of the settlement are confidential. The FDA approved YESAFILI™ in May 2024. In addition, Biocon had secured a settlement agreement in Canada for the launch of YESAFILI™ by July 1, 2025.
Stay tuned to Big Molecule Watch as we continue to monitor key developments in ongoing BPCIA litigations and the biosimilars market.