FDA Approves Actemra Biosimilar
Celltrion’s Avtozma has been indicated for the treatment of giant cell arteritis, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis, systemic juvenile idiopathic arthritis, and COVID-19—in the same dosages and formulations as its tocilizumab reference product.
The FDA has officially approved Celltrion’s Avtozma (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to Actemra.1 This biosimilar is indicated for the treatment of giant cell arteritis, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis, and COVID-19.2
The agency’s decision was powered by a multitude of supporting evidence, including results from a Phase III study indicating biosimilarity between Avtozma and reference product tocilizumab in patients with moderate to severe active RA.
The primary outcome, specifically regarding the change from baseline in disease activity score using 28 joints (DAS28)-ESR at Week 24, and the final one-year results, suggested comparability in secondary efficacy, pharmacokinetic (PK), safety, and immunogenicity results between Avtozma and reference tocilizumab. Given what is required by a biosimilar, these clinical results validated that Avtozma and its reference tocilizumab are extremely similar and have no clinically meaningful differences regarding efficacy, safety, pharmacokinetics (PK) and immunogenicity.3
"Introducing both IV and SC formulations of Avtozma provides flexibility and a wider range of treatment options," said Thomas Nusbickel, Celltrion USA’s chief commercial officer. "This approval represents a strategic addition to our immunology portfolio, further strengthening our commitment to delivering accessible and high-quality treatment options for patients and healthcare providers. Our goal is to provide safe and effective alternatives and ensure appropriate access so plan sponsors can address unique population needs."
The IV infusion is offered in 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL), while SC injection is available. in 162 mg/0.9 mL in a single-dose prefilled syringe or single-dose autoinjector.
Avtozma represents the biopharma company’s seventh biosimilar that has been granted US marketing authorization, with the sixth coming late last year for Steqeyma (ustekinumab-stba)4 as a biosimilar to Stelara (ustekinumab)—in the IV and SC variety—for adults and children with plaque psoriasis and psoriatic arthritis, along with adults with Crohn's disease and ulcerative colitis. Ustekinumab is a fully human monoclonal antibody that hinders interleukin (IL)-12 and IL-23, two cytokines that play a role in inflammatory and immune responses.
"The approval of Steqeyma reflects Celltrion's continued investment in providing treatment options to patients diagnosed with ulcerative colitis, Crohn's disease, psoriasis, and psoriatic arthritis," added Nusbickel. "… Our portfolio, supported by our fully integrated platform, establishes Celltrion USA as an important player in the US immunology market."
Celltrion was granted a license entry date for Steqeyma in the US of February 2025.
References
1. US FDA approves Celltrion's AVTOZMA (tocilizumab-anoh), a biosimilar to ACTEMRA. PR Newswire. January 30, 2025. Accessed January 31, 2025. https://www.prnewswire.com/news-releases/us-fda-approves-celltrions-avtozma-tocilizumab-anoh-a-biosimilar-to-actemra-302364951.html
2. AVTOZMA US prescribing information (2024)
3. Gerd Burmester et al., Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study. Poster Presentation (abstract no. 0502). Presented at ACR 2024. https://acrabstracts.org/abstract/similar-efficacy-pk-safety-and-immunogenicity-of-tocilizumab-biosimilar-ct-p47-and-reference-tocilizumab-in-patients-with-moderate-to-severe-active-rheumatoid-arthritis-week-52-results-from-the/
4. US FDA approves Celltrion's Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab). Celltrion. December 18, 2024. Accessed January 31, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/3629
