Tagged as: Regeneron

Regeneron Files First BPCIA Complaint Regarding Biosimilar Eylea Against Mylan in West Virginia District Court

Regeneron filed a complaint yesterday against Mylan in the U.S. District Court for the Northern District of West Virginia, alleging infringement of twenty-four patents under the BPCIA based on Mylan’s submission of an aBLA for M710, a proposed biosimilar of EYLEA (aflibercept).  Regeneron asserts that use of Mylan’s M710 infringes seven…

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Regeneron Files Antitrust Lawsuit - Big Molecule Watch

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 campaign to deny patients the life-saving benefits of [] Regeneron’s cholesterol-reducing medication, Praluent® (alirocumab).”  According to Regeneron,…

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FDA Accepts Regeneron and Sanofi’s DUPIXENT (Dupilumab) sBLA for Priority Review

Last week, Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has accepted a Priority Review of the supplemental Biologics License Application (sBLA) for DUPIXENT (dupilumab) 300 mg weekly to treat patients aged 12 years and older with eosinophilic esophagitis (EoE).  EoE is a chronic, immune-mediated, atopic inflammatory condition of…

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Regeneron’s Disclaimer of Aflibercept Formulation Patent Causes PTAB Denial of Institution of Celltrion PGR

On March 15, 2022, the Patent Trial and Appeal Board (PTAB) denied institution of post-grant review (PGR) proceedings initiated by Celltrion Inc. concerning Regeneron Pharmaceutical’s U.S. Patent No. 10,857,231 (the ’231 Patent) after Regeneron disclaimed the patent.  The ’231 patent has claims directed to formulations of aflibercept, the active ingredient…

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European Patent Office rules in favor of Sanofi and Regeneron concerning Praluent® (alirocumab)

On October 29, 2020, the European Patent Office ruled in favor of Sanofi and Regeneron in their dispute concerning Amgen’s Praluent® (alirocumab) patent.  The EPO found invalid certain claims of Amgen’s European patent, EP 2 215 124, which is directed to PCSK9 antibodies.  This EPO decision follows a ruling in…

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Alteogen reports similarity between its biosimilar ALT-L9 and Eylea®

South Korea’s Alteogen announced that its aflibercept biosimilar ALT-L9 had demonstrated similarity to the originator with no significant side effects in Michigan-based non-clinical trials. Aflibercept, known commercially as Eylea®, is sold by Regeneron for the treatment of wet age-related macular degeneration, which is the leading cause of blindness among the elderly….

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