Bio-Thera and STADA have expanded their strategic biosimilars alliance to include a tocilizumab product. The agreement grants STADA exclusive commercialization rights across Europe, leveraging Bio-Thera's development and manufacturing expertise for this Roche RoActemra biosimilar.
Bio-Thera Solutions and Stada announced in August 2025 an expansion of their existing biosimilars alliance to include tocilizumab biosimilar, referencing Roche’s RoActemra.
Under the agreement, Bio-Thera will maintain responsibility for the development, manufacturing, and supply of the tocilizumab biosimilar. Stada and its affiliates will hold exclusive commercialization rights in the European Union, the UK, Switzerland, and other selected countries.
The partnership leverages Bio-Thera's proven expertise with tocilizumab, demonstrated by its product, Tofidence (tocilizumab-bavi), which was approved in the US on 29 September 2023, as the first tocilizumab biosimilar [1] and was subsequently launched by Organon in May 2025 after it acquired the asset from Biogen. The product also received European Commission approval on 20 June 2024 [2, 3].
This new collaboration builds upon the company’s existing collaboration for BAT2506, a biosimilar candidate to Simponi (golimumab), which was announced in May 2024 [4]. A marketing authorization application (MAA) for BAT2506 has since been accepted for review by the European Medicines Agency.
Currently, three tocilizumab biosimilars are approved in Europe and the US, see Table 1.
| Table 1: Overview of tocilizumab approved in Europea and the US*
|
| Product name (Europe)
|
Authorization date
|
Product name (USA)
|
Authorization date
|
Manufacturer/Company name
|
| Avtozma
|
14 Feb 2025
|
Avtozma (tocilizumab-anoh)
|
24 Jan 2025
|
Celltrion
|
| Tofidence
|
20 Jun 2024
|
Tofidence (tocilizumab-bavi)
|
29 Sep 2023
|
Europe: Biogen in Europe
USA: Bio-Thera Solutions, marketed by Biogen
|
| Tyenne
|
15 Sep 2023
|
Tyenne (tocilizumab-aazg)
|
7 Mar 2024
|
Fresenius Kabi Deutschland GmbH
|
| *Data updated 20 October 2025
|
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first tocilizumab biosimilar Tofidence [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 20]. Available from:
www.gabionline.net/biosimilars/news/fda-approves-first-tocilizumab-biosimilar-tofidence
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of biosimilar tocilizumab Tofidence and ustekinumab Wezenla [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 20]. Available from:
www.gabionline.net/biosimilars/news/ema-recommends-approval-of-biosimilar-tocilizumab-tofidence-and-ustekinumab-wezenla
3. GaBI Online - Generics and Biosimilars Initiative. EC approvals of four biosimilars: Tofidence, Wezenla, Avzivi and SteQeyma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 20]. Available from: www.gabionline.net/biosimilars/news/ec-approvals-of-four-biosimilars-tofidence-wezenla-avzivi-and-steqeyma
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