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Amgen Launches Its Aflibercept Biosimilar In the U.S.

After the Federal Circuit’s denial last month of Regeneron’s motion for an injunction pending appeal, seeking to prevent Amgen from launching its aflibercept biosimilar, Amgen announced on its Q3 earnings call last week that it has launched its aflibercept biosimilar, PAVBLU.  On the call, Murdo Gordon, Amgen’s Executive Vice President of…

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Genentech, Roche, and Biogen Sue Dr. Reddy's and Fresenius for a Proposed Biosimilar of Rituxan in District of New Jersey

Genentech, Roche, and Biogen filed a Complaint on November 17 against Dr. Reddy’s Laboratories (“DRL”) and Fresenius in the U.S. District Court for the District of New Jersey, alleging infringement of 15 patents under the BPCIA based on DRL’s submission of an aBLA for DRL_RI, a proposed biosimilar of RITUXAN (rituximab)…

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Regeneron Moves to Terminate Celltrion IPR on Aflibercept Patent After Regeneron Files Statutory Disclaimer

Last week, Regeneron filed a motion to terminate IPR2023-00620, an IPR filed by Celltrion on February 28, 2023, seeking cancellation of claims 1-4 of Regeneron’s U.S. Patent No. 10,406,226 which is generally directed to methods of manufacturing VEG-F antagonists, including aflibercept.  Regeneron’s motion to terminate is based on Regeneron’s filing…

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Delaware District Court Adopts Magistrate Judge’s Report and Recommendation Denying Amgen’s Motion to Dismiss Regeneron’s Antitrust Claims, Overruling Amgen’s Objections

As we previously reported, Magistrate Judge Hall issued a Report and Recommendation (“R&R”) on February 10, 2023 denying Amgen’s motion to dismiss Regeneron’s antitrust claims in Regeneron Pharmaceuticals, Inc. v. Amgen Inc., 22-cv-697 pending in the district of Delaware.  On February 24, 2023, Amgen filed its Objections to the Report…

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Janssen Files Redacted Public Version of Its Opening Brief in Support of Its Motion for Preliminary Injunction Against Amgen in BPCIA Ustekinumab Case

As we previously reported, on March 1, 2023, Janssen filed a motion for preliminary injunction in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN, seeking to enjoin Amgen from the commercial manufacturing, sale, and offer for sale of ABP 654, Amgen’s ustekinumab biosimilar.  Last week, Janssen filed a public…

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Mylan Files IPR on Regeneron Aflibercept Patent

Mylan Pharmaceuticals Inc. recently filed an IPR petition, PTAB-IPR2023-00099, seeking cancellation of claims 1-3 of U.S. Patent No. 10,857,205, assigned to Regeneron Pharmaceuticals, Inc.  According to the petition, the claims “are drawn to monthly dosing [of aflibercept] to treat an angiogenic eye disorder.”  The Petition sets forth three anticipation grounds and…

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Switching Study Concludes That Transition From Humira To Samsung Bioepis’s Adalimumab Biosimilar Is Safe and Effective

Results of the PROPER study, an interim analysis assessing the safety and efficacy of switching from Abbvie’s Humira to Samsung Bioepsis’s biosimilar adalimumab product, SB5, were presented last week at the European Crohn’s and Colitis Organization’s annual meeting.  SB5 received EU marketing authorization in August 2017.  According to the presentation, the…

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FDA Completes Safety Review of Lannett’s IND for Insulin Glargine Biosimilar

Lannett Company, Inc. (“Lannett”) announced Friday that the FDA has completed its safety review of Lannett’s Investigational New Drug application for Lannett’s insulin glargine biosimilar, a product Lannett is co-developing with its strategic alliance partners within the HEC group of companies, and has concluded that the company may proceed with…

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