The ACR/CHEST ILD Guidelines in Practice: Watch the Webinar Recording Now!

An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

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.

ADVERTISEMENT
SCROLL TO CONTINUE

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.

ADVERTISEMENT
SCROLL TO CONTINUE

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.

Related Articles

    Psoriatic Arthritis Drugs at a Glance, 2023

    Biosimilars have become a therapeutic turning point for many patients who are living with rheumatic illnesses. Psoriatic arthritis (PsA) is a complex, multi-faceted chronic inflammatory musculoskeletal and skin disease where the treatment has changed considerably over the past few years. Psoriatic arthritis has an impact on about 30% of people with psoriasis.1 In 2019, the…

    Possible Impact of Biosimilar Infliximab on U.S. Market in Prescriptions, Pricing

    The use of biosimilars for rheuma­tology in the U.S. became a reality when the U.S. Food and Drug Administration (FDA) approved Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), in April. What this may mean is increased competition among drug companies with regard to pricing and, therefore, potentially lower costs for U.S. patients, according to Seoyoung…

    FDA Provides 2020 Rheumatology Drug Update

    Three FDA representatives discuss new drug indications, safety precautions and label changes, & an emergency program to rapidly evaluate existing immunomodulating therapies for use in COVID-19 patients.