On 24 January 2025, the US Food and Drug Administration (FDA) has approved tocilizumab biosimilar, Avtozma (tocilizumab-anoh). Celltrion’s Avtozma (tocilizumab-anoh)/CT-P47 is a biosimilar referencing Roche/Genentech’s Actemra/RoActemra (tocilizumab).
Avtozma (tocilizumab-anoh) will be available in both intravenous (IV) and subcutaneous (SC) formulations of various strengths. For IV injectable, it's available in 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL, while SC injectable is available in 162 mg/0.9 mL. Avtozma has been approved for multiple indications, including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and COVID-19.
The FDA's decision is based on a comprehensive data package and the totality of evidence, including the results from a phase III study demonstrating biosimilarity between Avtozma and reference tocilizumab in patients with moderate to severe active RA. The primary endpoint was met in terms of change from baseline in disease activity score using 28 joints (DAS28)-ESR at Week 24, and the final 1-year results supported comparability in secondary efficacy, pharmacokinetic (PK), safety and immunogenicity results between Avtozma and reference tocilizumab. The clinical results demonstrated that Avtozma and its reference tocilizumab are highly similar and have no clinically meaningful differences in terms of efficacy, safety, pharmacokinetics (PK) and immunogenicity.
Avtozma has also received a positive opinion from the EMA’s CHMP in Europe [1]. In fact, two other tocilizumab biosimilars — Tyenne and Tofidence — have been approved in Europe and the US during 2023 and 2024, as shown in Table 1.
| Table 1: Tocilizumab biosimilars approved in Europe and the US
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| Product name
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Authorization date
|
Manufacturer/Company name
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| Approved by the European Commission
|
| Avtozma
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CHMP positive opinion 12 Dec 2024
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Celltrion - 23 Feb 2025
|
| Tofidence
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20 Jun 2024
|
Biogen
|
| Tyenne
|
15 Sep 2023
|
Fresenius Kabi Deutschland GmbH
|
| Approved by the US FDA
|
| Avtozma (tocilizumab-anoh)
|
24 Jan 2025
|
Celltrion
|
| Tofidence (tocilizumab-bavi)
|
29 Sep 2023
|
Bio-Thera Solutions, marketed by Biogen
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| Tyenne (tocilizumab-aazg)
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7 Mar 2024
|
Fresenius Kabi
|
| *Data updated 5 March 2025
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Two tocilizumab biosimilars, Dr Reddy’s DRL_TC and Mycenax Biotech/Gedeon Richter’s LusiNEX, are in the clinical trial phase.
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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for tocilizumab biosimilar Avtozma and filgrastim biosimilar Zefylti [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 5]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-tocilizumab-biosimilar-avtozma-and-filgrastim-biosimilar-zefylti
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 5]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 5]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us
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