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FDA Approves Tocilizumab Biosimilar; Plus New Lupus Drug in Early Trials

  |  Issue: July 2024  |  

Tocilizumab-aazg (Tyenne) is the first tocilizumab biosimilar with both intravenous and subcutaneous administration options to be approved by the U.S. Food & Drug Administration (FDA).1 In September 2023, tocilizumab-bavi (Tofidence) was the first biosimilar to tocilizumab (Actemra) to be approved. However, it is approved for intravenous administration only.2

Like Actemra, tocilizumab-aazg (Tyenne) is an interleukin 6 receptor antagonist used to treat autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. Serious infections, including tuberculosis, bacterial, invasive fungal, viral and other opportunistic infections have occurred in patients receiving the drug. Tocilizumab-aazg is contraindicated in patients with known hypersensitivity to tocilizumab products.

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Investigational New Drug Application Approved for CB-010

The FDA accepted the investigational new drug application for CB-101, a chimeric antigen receptor T cell therapy for treating lupus nephritis and extra-renal lupus.3 A phase 1, multi-center, open-label clinical trial is expected to start by the end of 2024. This trial, known as GALLOP, will include partial human leukocyte antigen matching between donor sources and patients, which may improve clinical outcomes. CB-101 is currently undergoing clinical trials for patients with relapsed or refractory B cell non-Hodgkin’s lymphoma.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

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References

  1. Fresenius accelerates momentum in its (bio)pharma business and launches Tyenne, its third approved biosimilar in the U.S. [news release]. Fresenius Kabi. 2024 Apr 15.
  2. FDA approves first biosimilar to Actemra to treat adult and pediatric arthritis [news release]. U.S. Food & Drug Administration. 2023 Sep 29.
  3. Caribou Biosciences expands clinical development of CB-010 with FDA clearance of IND in lupus [news release]. Caribou Biosciences. 2024 Apr 4.

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