Novel Drug & Emergent Therapeutics | Pharmaceuticals | Rare Diseases
U.S. FDA approves biosimilar AVTOZMA® (tocilizumab-anoh) for multiple rheumatic conditions
Time to read: 01:04
Originally published: 30 January 2025
Source: PRNewswire
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDR004
Category: Rare Diseases
Crossreference: Rheumatology, Paediatric & Neonatologoy
Category tags: rheumatoid arthritis, giant ceell arteritis, juvenile idiopathic arthritis, biosimilars
| Product Category | Product Name | Company | Status |
|---|---|---|---|
| Complete |
Here’s an expanded version with more details on Avtozma’s use and clinical trial results:
The U.S. Food and Drug Administration (FDA) has approved Avtozma (tocilizumab-anoh), a tocilizumab biosimilar developed by Celltrion, for the treatment of multiple rheumatic conditions. It is the third biosimilar referencing Actemra (tocilizumab) to gain U.S. approval.
Avtozma, an interleukin-6 (IL-6) receptor antagonist, is indicated for rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), and COVID-19. It is available in both intravenous (IV) and subcutaneous (SC) formulations, offering flexibility for administration. The IV formulation is dosed at 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL, while the SC version comes in a 162 mg/0.9 mL prefilled syringe or autoinjector.
The approval was supported by a 52-week Phase 3 randomized clinical trial (NCT05489224) evaluating the efficacy, pharmacokinetics, safety, and immunogenicity of Avtozma in comparison with Actemra. The trial enrolled 471 patients with moderate-to-severe RA who had an inadequate response to at least one disease-modifying antirheumatic drug (DMARD). Patients were randomized (1:1) to receive 8 mg/kg of either Avtozma or reference tocilizumab IV every four weeks for 20 weeks. At week twenty-four, 444 patients were re-randomized to either continue their original treatment or switch from reference to Avtozma, continuing therapy until week 48, with a four-week follow-up period.
Results showed that clinical improvements were sustained through week 52, with comparable response and remission rates between groups. The mean pre-dose serum drug concentrations at week 52 were similar in the Avtozma, reference, and switched groups (16.73 µg/mL, 17.41 µg/mL, and 17.32 µg/mL, respectively). Safety profiles remained consistent, with no new safety concerns identified. Immunogenicity rates were low and comparable, with 4.4%–4.6% of patients developing antidrug antibodies and 1.8% developing neutralizing antibodies.
Avtozma is Celltrion’s seventh biosimilar to receive U.S. approval. It joins previously approved tocilizumab biosimilars Tofidence (Biogen/Bio-Thera Solutions) and Tyenne (Fresenius Kabi), expanding treatment options for inflammatory conditions.
The FDA warns that Avtozma, like other tocilizumab products, carries risks of serious infections, hepatotoxicity, and hypersensitivity reactions. Patients should be monitored for infections, liver enzyme elevations, and potential immunosuppressive effects.
| Clinical Trial Status | ClinicalTrial.gov Registration | Study Name |
|---|---|---|
|
A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis |
Access the Original Press Release
31 January 2025 | Centre for Biosiimilars | FDA Approves Celltrion's Avtozma as Third Tocilizumab Biosimilar
3 February 2025 | Medscape | FDA Approves Third Tocilizumab Biosimilar
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