Search Results: Uncategorized

REGENXBIO and Sarepta Agree to Stay Litigation Pending Outcome of Sarepta’s IPR Petition

As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware in June 2023 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, ELEVIDYS (delandistrogene moxeparvovec-rokl).  On September 19,…

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Fresenius Kabi and Formycon Reach Settlement Agreement for Ustekinumab Biosimilar Candidate in Europe and Canada

On March 18, 2024, Fresenius Kabi (“Fresenius”) and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada.  The terms of the settlement are confidential.  According to the press release, the settlement agreement aligns with Fresenius’s recent achievements in…

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FDA Approves First Gene Therapy to Treat Children with Metachromatic Leukodystrophy

On March 18, 2024, the FDA approved Orchard Therapeutics’ LENMELDY, the first approved gene therapy for the treatment of children with metachromatic leukodysrophy (MLD).  MLD is a rare, fatal genetic disease affecting approximately one in every 40,000 individuals in the U.S.  LENMELDY is made from patient’s own hematopoietic (blood) stem…

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Biden Administration Proposes Biosimilar Substitution Without Interchangeability

The Biden Administration recently released a 2025 Budget Proposal which includes permitting biosimilar substitution without the Food and Drug Administration’s (“FDA”) separate determination of interchangeability.  Specifically, the U.S. Department of Health & Human Services (HHS)’s 2025 proposed budget includes a budget-neutral provision for allowing biosimilar substitution without a separate determination…

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Celltrion Announces Commercial Availability of ZYMFENTRA™ (infliximab-dyyb)

Celltrion USA announced on March 18, 2024, the availability of ZYMFENTRA™ (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab.  ZYMFENTRA™, approved by the FDA in October 2023, is the first FDA-approved SC infliximab for the treatment of moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease, with…

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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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Fresenius Kabi Announces FDA Approval of TYENNE, a Tocilizumab Biosimilar Referencing ACTEMRA

On March 7, Fresenius Kabi announced that the FDA has approved its tocilizumab biosimilar, TYENNE (tocilizumab-aazg) for inflammatory and immune diseases indications including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.  TYENNE is the second FDA approved biosimilar of ACTEMRA (following Biogen’s TOFIDENCE (tocilizumab-bavi)…

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