Biosimilars of tocilizumab

Biosimilars/General | Posted 29/07/2016 post-comment0 Post your comment

Last update: 4 December 2020

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.

Toclizumab Roche V16G29

The originator product, Roche’s Actemra/RoActemra (tocilizumab), was approved by the US Food and Drug Administration (FDA) on 8 January 2010 and on 16 January 2009 by the European Medicines Agency (EMA) [1]. Tocilizumab was approved in Japan for Castleman’s disease in June 2005. Actemra/RoActemra had worldwide sales of CHF 1.4 billion (US$1.4 billion) in 2015.

The patents on Actemra/RoActemra expired in the US on 22 December 2015 and will expire in Europe on 23 April 2017 [1]. Some of the tocilizumab biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

Table 1: Biosimilars and non-originator biologicals* of tocilizumab approved or in development
Company name, Country Product name Stage of development
Bio‑Thera Solutions, China* BAT1806 Phase I PK and safety study started in July 2018. Phase III study started in January 2019 [2]
Epirus Biopharmaceuticals, USA BOW070 Preclinical. Focussed on Castleman’s disease [3]
Hisun Pharmaceuticals, China* HS628 Results of physicochemical and biological characterization reported in March 2017 [4]
Mycenax, Taiwan LusiNEX Positive results from phase I study reported in December 2018 [5]
Made a deal with Richter in April 2020 to sell LusiNEX [6]
PK: Pharmacokinetics
*See editor’s comment

On 9 May 2016, Epirus Biopharmaceuticals announced that it was reprioritizing its pipeline to solely focus on biosimilars to treat rare diseases. These include BOW080 (eculizumab biosimilar) and BOW070 (tocilizumab biosimilar). Epirus expects to file for approval of BOW080 in 2020 [3].

On 24 January 2019, Bio-Thera announced that it had started dosing rheumatoid arthritis patients in a global phase III trial for its tocilizumab copy biological, BAT1806 [3].

Results of physicochemical and biological characterization reported that Hisun’s HS628 copy biological has an identical amino acid sequence to tocilizumab, and the same structure. The drug also had similar post-translational modifications, charge and size to the originator drug. Size exclusion chromatography and capillary electrophoresis confirmed the purity of the copy biological [4].

Taiwanese biosimilars developer Mycenax announced on 28 April 2020 that it had made a deal with Hungary-based Gedeon Richter (Richter) to sell its LusiNEX (tocilizumab) biosimilar project, including cell banks, chemistry, manufacturing and controls (CMC) technology, intellectual properties and clinical trial results to Richter for a total of US$16.5 million [6].

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted ‘copy biologicals’ approved in China and other ‘non-originator biologicals’ approved outside Europe might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera advances bevacizumab and tocilizumab copy biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/News/Bio-Thera-advances-bevacizumab-and-tocilizumab-copy-biologicals 
3. GaBI Online - Generics and Biosimilars Initiative. Epirus expands biosimilars pipeline with Bioceros acquisition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 May 19]. Available from: www.gabionline.net/Pharma-News/Epirus-expands-biosimilars-pipeline-with-Bioceros-acquisition 
4. GaBI Online - Generics and Biosimilars Initiative. Physicochemical and biological characterization study of copy biological tocilizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/Research/Physicochemical-and-biological-characterization-study-of-copy-biological-tocilizumab 
5. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for Mycenax’s tocilizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-results-for-Mycenax-s-tocilizumab- biosimilar 
6. GaBI Online - Generics and Biosimilars Initiative. Mycenax sells tocilizumab biosimilar to Richter [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Pharma-News/Mycenax-sells-tocilizumab-biosimilar-to-Richter

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Source: EMA, Epirus, Roche

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