FDA approves first tocilizumab biosimilar Tofidence

Biosimilars/News | Posted 17/10/2023 post-comment0 Post your comment

On 29 September 2023, the US Food and Drug Administration approved Tofidence (tocilizumab-bavi) as the first biosimilar to Actemra (tocilizumab). Tofidence is first-of-its-kind biosimilar tocilizumab to receive approval in the US.

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Tofidence was developed as a result of a partnership between Biogen and Bio-Thera Solutions [1]. FDA first accepted the partnership’s abbreviated Biologics License Application (BLA) for Tofidence, review in December 2022 [2]. It is a biosimilar of Roche’s Actemra/RoActemra (tocilizumab).

Tocilizumab is a humanized monoclonal antibody which acts against the interleukin-6 receptor (IL-6R). It is an immunosuppressive drug used mainly for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis, a severe form of arthritis in children [3].

In Japan, tocilizumab is also approved for the treatment of Castleman’s disease, a rare benign tumour of B cells.

Tofidence is now approved for the following indications currently approved for US-licensed Actemra: Rheumatoid Arthritis in adults, Polyarticular Juvenile Idiopathic Arthritis ages 2 and older, and Systemic Juvenile Idiopathic Arthritis ages 2 and older. This is the first biosimilar approved to treat systemic juvenile idiopathic arthritis. Tofidence is administered via intravenous infusion. 

The price of Tofidence has not yet been announced, yet as a biosimilar, it is expected to come in at prices more affordable than the originator product. ‘The approval of Tofidence in the US marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,’ said Ian Henshaw, Global Head of Biosimilars at Biogen. ‘With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for health care systems and an increase in physician choice and patient access to biologics.’

In Europe, the first tocilizumab biosimilar approved is Fresenius Kabi’s Tyenne. This was approved in July 2023 and is available in both subcutaneous and intravenous formulations [4].

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1. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera launches first adalimumab copy biological in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 17]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. FDA and EMA file acceptance of Biogen’s tocilizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 17]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of tocilizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 17]. Available form:
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of first aflibercept and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Oct 17]. Available from:

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