Tagged as: Aflibercept

DOJ Files False Claims Act Complaint Against Regeneron, Alleging Fraudulent Eylea Drug Pricing

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 in 2020.  The DOJ recently announced that it has filed another False Claims Act complaint against Regeneron Pharmaceuticals, alleging that…

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Federal Circuit Dismisses Appeals in Regeneron v. Mylan (Aflibercept) BPCIA Litigation

As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, “the Biocon Defendants”) regarding the Biocon Defendants’ proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia.  On December 27, 2023, the court entered judgment in the…

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Updates on Aflibercept BPCIA Litigation

Regeneron’s request for multi-district litigation As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a motion seeking to establish a multi-district litigation (“MDL”) encompassing the aflibercept BPCIA cases it has filed in the U.S. District Court for the Northern District of West Virginia and transfer its case against…

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Biocon Settles with Bayer and Regeneron, Securing Canada Market Entry Date for Aflibercept Biosimilar

On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon’s proposed biosimilar to EYLEA (aflibercept). The settlement resolves multiple patent infringement proceedings in the Federal Court of Canada. Under the agreement, Biocon can launch YESAFILI in Canada…

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Post-Trial Updates on Regeneron v. Mylan (Aflibercept) BPCIA Litigation

Appeals from and redacted memorandum and opinion in support of judgment in Regeneron v. Mylan (aflibercept) BPCIA case filed As we previously reported, trial in Regeneron Pharmaceutical, Inc.’s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, “the Biocon Defendants”) regarding the Biocon Defendants’ proposed aflibercept biosimilar concluded…

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