On April 18, 2025, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the supplemental Biologics License Application for EYLEA HD...more
On February 18, 2025, the U.S. Court of Appeals for the First Circuit added its voice to a growing chorus of appellate courts to elevate the standard of proof required to show a violation of the federal False Claims Act in...more
On February 18, 2025, Alvotech and Teva announced the FDA acceptance of an aBLA for AVT06 (aflibercept), a proposed biosimilar of Regeneron’s EYLEA® (aflibercept). This aBLA joins Celltrion’s CT-P42 (aflibercept) awaiting...more
Amgen announced during its Q3 2024 Earnings Call that it had launched Pavblu™ (aflibercept-ayyh) as the first biosimilar of Regeneron’s EYLEA® (aflibercept) to be marketed in the U.S....more
On June 11, 2024, the Court in Case No. 1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) issued a permanent injunction against the launch of Biocon and Mylan’s Yesafili™ (aflibercept-jbvf), a recently approved...more
As we previously reported, the U.S. Department of Justice (“DOJ”) filed a lawsuit under the Anti-Kickback Statute against Regeneron Pharmaceuticals in the District of Massachusetts regarding Regeneron’s sales of Eylea...more
In an appeal that attracted a dozen amici, including the Department of Justice, the Federal Trade Commission, five states, and the District of Columbia, the Second Circuit gave the Walker Process antitrust doctrine a shot in...more
On January 10, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint in the U.S. District Court for the Central District of California against Amgen Inc. (“Amgen”) alleging infringement of 32 patents under the...more
As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and...more
On November 8, 2023, Regeneron Pharmaceuticals Inc. filed a BPCIA Complaint against Celltrion Inc. in the district court for the northern district of West Virginia, asking the Court to block Celltrion’s biosimilar product...more
On August 18, 2023, Regeneron Pharmaceuticals, Inc. (“Regeneron”) announced that the FDA approved EYLEA HD®, an 8 mg injection of EYLEA® (aflibercept). EYLEA HD®, jointly developed with Bayer A.G., is approved for the...more
On February 8, 2023, Regeneron announced that the FDA approved its EYLEA® (aflibercept) injection for the treatment of retinopathy of prematurity (ROP) in preterm infants—the first pediatric approval for this indication. ...more
Late last week, Regeneron Pharmaceuticals, Inc. filed an antitrust complaint against Amgen Inc. in the U.S. District Court for the District of Delaware. Regeneron alleges that “Amgen is engaged in a persistent exclusionary...more
Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011, and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal...more