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FDA Releases Draft Labeling Guidance for Biosimilar Products

Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for Biosimilar Products.”  FDA noted that this 2023 Draft Guidance reflects recommendations based on the “valuable experience about labeling considerations” that FDA…

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Sarepta and Catalent File Answers in REGENXBIO v. Sarepta Litigation

As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc., alleging infringement of U.S. Patent No. 11,680,274 by Sarepta’s gene therapy product. Sarepta’s gene therapy product, SRP-9001, was approved this June…

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Post-Trial Briefing in Regeneron v. Mylan Aflibercept BPCIA Case

Trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia.  As we previously reported, the case was expedited, with trial occurring less than a year after Regeneron filed its complaint.  The case was originally filed naming…

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Samsung Files IPR Petition on Regeneron's Aflibercept Patent

Last week, Samsung Bioepis filed an IPR petition challenging claims of U.S. Patent No. 11,253,572 (“the ’572 patent”), owned by Regeneron Pharmaceuticals.  According to the petition, the claims are directed to the use of aflibercept to treat angiogenic eye disorders, including diabetic macular edema and age-related macular degeneration. As we…

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White House Announces “Bold Goals” for Biotech

In a report entitled “Bold Goals for U.S. Biotechnology and Biomanufacturing,” the White House recently announced several biotech-related “bold goals” to advance the environmental, agricultural, economic, health, and science fields.  The publication follows President Biden’s Sept. 12, 2022 Executive Order on “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe,…

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Court Denies Amgen’s Motion to Dismiss and Motion to Stay Regeneron’s Antitrust Case

We previously reported on Regeneron’s antitrust suit against Amgen in the U.S. District Court for the District of Delaware.  The case concerns Regeneron’s allegation that Amgen has violated antitrust law by engaging “in a persistent exclusionary campaign to deny patients the life-saving benefits of [] Regeneron’s cholesterol-reducing medication, Praluent® (alirocumab).” …

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Chinese Market Biosimilar Update

This week, Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of ACTEMRA (tocilizumab).  BAT1806 is approved for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), and cytokine release syndrome (CRS), and is the first tocilizumab biosimilar approved by any…

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BPCIA Aflibercept Litigation: Mylan Seeks Leave to Add a Declaratory Judgment Counterclaim of No Lost Profits or Injunctive Relief

As we previously reported, the Northern District of West Virginia ordered an expedited trial in Regeneron’s aflibercept BPCIA case against Mylan.  Regeneron had asserted 24 patents in its complaint.  As required by the court’s scheduling order, on October 28, Regeneron identified six patents for the first phase of the litigation. …

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Celltrion’s CT-P6 Demonstrates Equivalent Safety, Efficacy With HERCEPTIN

A recently-published study reported that Celltrion’s CT-P6 (HERZUMA, trastuzumab-pkrb) demonstrated equivalent safety and efficacy compared with reference drug HERCEPTIN when used to treat patients with HER2-positive advanced gastric cancer.  This is the first study to directly compare the safety and efficacy of CT-P6 against HERCEPTIN in patients with advanced gastric…

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RELEUKO Receives FDA Approval

Amneal Pharmaceuticals and Kashiv Biosciences have announced that their RELEUKO (filgrastim-ayow) biosimilar recently received FDA approval, making it the third filgrastim biosimilar approved for the United States, as well as the FDA’s first biosimilar approval this year.  RELEUKO references Neupogen®, and is expected to launch in the third quarter of…

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