Tagged as: Regulatory

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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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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Teva and Alvotech’s Adalimumab Biosimilar Receives Interchangeable Status at FDA

On February 23rd, 2024, Alvotech and Teva announced FDA’s approval of SIMLANDI (adalimumab-ryvk), the first high-concentration and citrate-free biosimilar interchangeable with Humira. SIMLANDI injection was approved for nine indications—rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s Disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurative, and uveitis. The approval follows…

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Artiva Biotherapeutics Receives FDA Fast Track Designation for AlloNK in Lupus Nephritis

On February 22, 2024, Artiva announced that the FDA has granted Fast Track designation to Artiva’s AlloNK (AB-101) for the treatment of lupus nephritis in combination with rituximab or obinutuzumab. AlloNK is an allogeneic, off-the shelf, NK cell therapy that is not genetically modified and designed to enhance the antibody-dependent…

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FDA Approves XOLAIR to Treat Children and Adults With One or More Food Allergies

Genentech announced on February 16, 2024, that the U.S. Food and Drug Administration (FDA) approved XOLAIR (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with Immunoglobulin E (IgE)-mediated…

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FDA Issues a Final Rule on Biologics License Applications, Investigational New Drug Applications and Master Files

On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.” …

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