FDA accepts application for tocilizumab biosimilar

Biosimilars/News | Posted 02/09/2022 post-comment0 Post your comment

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 1 August 2022 that the US Food and Drug Administration (FDA) had accepted the application for their proposed tocilizumab biosimilar (MSB11456).

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MSB11456 is a proposed biosimilar of Roche’s Actemra/RoActemra (tocilizumab), which had worldwide sales of CHF 3.6 billion (US$3.7 billion) in 2021 [1].

Tocilizumab is a humanized monoclonal antibody 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. In Japan, tocilizumab is also approved for the treatment of Castleman’s disease, a rare benign tumour of B cells [1].

The application is supported by analytical similarity and comprehensive clinical data. These are used to demonstrate similar pharmacokinetic, efficacy, safety, tolerability, and immunogenicity to the reference product, with and without switch from tocilizumab patients to MSB11456. The application includes presentations for both subcutaneous (pre-filled syringe and autoinjector) and intravenous administrations, which, according to Fresenius Kabi is ‘designed to provide a comprehensive offering for patients treated with tocilizumab’.

If approved, MSB11456 would be the first tocilizumab biosimilar to be approved in the US and would also mark Fresenius Kabi’s first biosimilar approval in the country. To date, there are no other tocilizumab biosimilars approved in the US or in Europe [2, 3]. The company has two other biosimilars approved in Europe; Idacio (adalimumab) and Stimufend (pegfilgrastim) [3].

Editor’s Comment
Readers interested to learn more about tocilizumab biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of tocilizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 2]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-tocilizumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 2]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-the-us
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Sep 2]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe

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Source: Fresenius Kabi

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