FDA Approves Celltrion’s Tocilizumab-anoh, Biosimilar to Actemra

Avtozma, the third biosimilar to Actemra, has received FDA approval for multiple inflammatory diseases and COVID-19, potentially expanding treatment access for patients. | Image Credit: Olivier Le Moal - stock.adobe.com

The FDA approved tocilizumab-anoh (Avtozma), the third biosimilar to reference tocilizumab (Actemra), for treatment of multiple diseases in both intravenous and subcutaneous formulations.1

Celltrion announced that tocilizumab-anoh is indicated to treat rheumatoid arthritis (RA), giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. Results from a phase 3 study (NCT05489224) demonstrated biosimilarity between tocilizumab-anoh, previously known as CT-P47, and the reference product among patients with moderate to severe RA, which supported the approval.

Researchers randomized patients with moderate to severe RA who had inadequate responses to at least 1 disease-modifying antirheumatic drug (n = 471) to receive 8 mg/kg of CT-P47 or reference tocilizumab intravenously every 4 weeks up to week 20.2 Researchers rerandomized patients before week 24 (n = 444) to either maintain current treatment or switch from reference tocilizumab to CT-P47, continuing treatment until week 48, followed by a 4-week period.

There were 444 patients (92.8%) in the rerandomized group, with 412 patients completing treatment (CT-P47, 225; reference tocilizumab, 109; switched to CT-P47, 110) and the study (CT-P47, 210; reference tocilizumab, 100; switched to CT-P47, 102).

Researchers found similar mean pre-dose serum concentrations in the CT-P47 (16.73 µg/mL), reference tocilizumab (17.41 µg/mL), and patients who switched to CT-P47 (17.32 µg/mL) groups up to week 52. Additionally, patients who had at least 1 antidrug antibody–positive result at post-treatment following rerandomization were similar across groups (CT-P47, 4.4%; reference tocilizumab, 4.6%; switched to CT-P47, 3.6%), while 1.8% of patients in each cohort had at least 1 neutralizing antibody–positive result.

The study met the primary endpoint from baseline in disease activity score using 28 joints (DAS28)-ESR at week 24.1 Transition from Actemra to CT-P47 at week 24 did not affect the average change from baseline of DAS28.2 Additionally, comparable improvement in clinical activity was observed up to the end-of-study visit in week 52. Researchers identified comparability in the efficacy, pharmacokinetic, safety, and immunogenicity results between Avtozma and reference tocilizumab.1

Tocilizumab-anoh comes as an intravenous infusion of 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL. The subcutaneous formulation comes in 162 mg/0.9 mL in a single-dose prefilled syringe or single-dose autoinjector.

“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,” Thomas Nusbickel, chief commercial officer at Celltrion, said in a statement.

Previously, the FDA approved Tofidence (tocilizumab-bavi) in 2023 and Tyenne (tocilizumab-aazg) in April 2024.3,4 Tocilizumab products are recombinant humanized monoclonal antibodies that target IL-6 receptors that bind to soluble and membrane-bound IL-6 receptors and inhibit signaling.3

Patients who received tocilizumab-anohmost commonly experienced (≥ 5%) upper respiratory tract infections, nasopharyngitis, headache, hypertension, elevated alanine aminotransferase, and injection site reactions.1

Tocilizumab-anoh is the seventh biosimilar developed and manufactured by Celltrion to receive FDA approval. Previously, Celltrion received FDA approvals for biosimilars infliximab-dyyb (Inflectra), rituximab-abbs (Truxima), trastuzumab-pkrb (Herzuma), bevacizumab-adcd (Vegzelma), adalimumab-aaty (Yuflyma), andustekinumab-stba (Steqeyma).

References

1. US FDA approves Celltrion’s Avtozma (tocilizumab-anoh), a biosimilar to Actemra. News release. Celltrion. January 30, 2025. Accessed January 31, 2025. https://www.celltrion.com/en-us/company/media-center/press-release/3668
2. Burmester G,Trefler J, Racewicz A, 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. Presented at: ACR Convergence 2024; November 14-19, 2024; Washington, DC. Accessed January 31, 2025.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
3. Jeremias S. FDA approves first tocilizumab biosimilar. The Center for Biosimilars®. October 5, 2023. Accessed January 31, 2025. https://www.centerforbiosimilars.com/view/fda-approves-first-tocilizumab-biosimilar
4. Jeremias S. FDA green lights second tocilizumab biosimilar. The Center for Biosimilars. March 7, 2024. Accessed January 31, 2025. https://www.centerforbiosimilars.com/view/fda-green-lights-second-tocilizumab-biosimilar