Clinical development programme of RGB-19 as a biosimilar to tocilizumab

Choy, Ernest ORCID: https://orcid.org/0000-0003-4459-8609, Dancer, Gordana, Horvát-Karajz, Károly, Kiefer, Joachim and Jeszenői, Norbert 2026. Clinical development programme of RGB-19 as a biosimilar to tocilizumab. Video Journal of Biomedicine 8 (1) , pp. 18-20. 10.1080/26315904.2026.2702116

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Abstract

IL-6 is a proinflammatory cytokine that contributes to the pathogenesis of rheumatoid arthritis (RA). Tocilizumab, an IL-6 receptor inhibitor, is an established RA treatment option, although access may be limited by biologic costs. RGB-19 is a proposed biosimilar to tocilizumab, developed to provide a comparable therapeutic alternative. This video manuscript summarises the RGB-19 clinical programme, including a Phase I pharmacokinetic (PK) and pharmacodynamic (PD) study in healthy adults and a Phase III efficacy and safety study in patients with RA. RGB192101 was a Phase I, randomised, double-blind, crossover trial comparing a single 162 mg SC dose of RGB-19 with tocilizumab in healthy Japanese men. PK equivalence for Cmax and AUCinf was demonstrated, with comparable PD, immunogenicity, and safety outcomes and no new safety signals identified. RGB19101 was a Phase III, randomised, double-blind, parallel-group trial evaluating IV RGB-19 (8 mg/kg every 4 weeks) versus tocilizumab as adjunct therapy to MTX in patients with active RA and an inadequate response to MTX. Clinical equivalence in efficacy at Week 12 was demonstrated, with sustained efficacy, safety, PK/PD, and immunogenicity through Week 52. Together, these studies demonstrated that RGB-19 provides outcomes comparable to tocilizumab, supporting its use as a biosimilar.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Schools > Medicine
Date of First Compliant Deposit:	10 August 2026
Date of Acceptance:	7 July 2026
Last Modified:	10 Aug 2026 14:00
URI:	https://orca.cardiff.ac.uk/id/eprint/188834

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