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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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Deal news: Bio-Thera Solutions and Intract Pharma

Bio-Thera Solutions and Intract Pharma announced at the end of last month that they had entered into a global collaboration and licensing agreement that gives Bio-Thera access to two oral delivery technologies for monoclonal antibodies to develop treatments for chronic gastrointestinal inflammatory diseases.  According to Intract’s press release, “Intract has…

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The FDA’s Purple Book

As we previously reported, the “Consolidated Appropriations Act” enacted in December of last year contained a provision that required FDA to create a searchable, electronic database of biologics and to update it with patent information provided to an applicant during the patent dance.  As of the effective date of June…

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Celltrion Shares Recent Biosimilar Development News

Celltrion Healthcare announced last week that it received positive results from the Phase III trial of its high-concentration, low-volume, citrate-free adalimumab biosimilar, CT-P17 or Yuflyma™, in patients with active rheumatoid arthritis (RA).  According to the press release, “[r]esults demonstrated comparable efficacy in terms of ACR20/50/70 response rates, both in patients…

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House Introduces Bill, BIOSIM Act, Designed To Lower Drug Costs

On April 23, 2021, Congressmen Schrader and Kinzinger introduced H.R. 2815, the Bolstering Innovative Option to Save Immediately on Medicines Act (“BIOSIM Act”).  The bill provides for temporary increased reimbursement to hospitals and doctors for biosimilar drugs from the average sales price (ASP) of the drug plus 6% to the…

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Women’s History Month: Janet Woodcock

In honor of Women’s History Month, Big Molecule Watch will highlight the work of women who have contributed to the advancement of biologics and biosimilars. One such individual is Janet Woodcock, current acting Commissioner of the U.S. Food and Drug Administration (FDA) and director for Drug Evaluation and Research, who has held a number…

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