Pharmacokinetics of a proposed tocilizumab biosimilar (MSB11456) versus US-licensed tocilizumab: results of a randomized, double-blind, single-intravenous dose study in healthy adults

Tomaszewska-Kiecana, Monika; Ullmann, Martin; Petit-Frere, Corinne; Monnet, Joëlle; Dagres, Christos; Illes, Andras

doi:10.1080/1744666x.2023.2174104

Expert Review of Clinical Immunology

2023

DOI: 10.1080/1744666x.2023.2174104

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Pharmacokinetics of a proposed tocilizumab biosimilar (MSB11456) versus US-licensed tocilizumab: results of a randomized, double-blind, single-intravenous dose study in healthy adults

Monika Tomaszewska-Kiecana¹,

Martin Ullmann²,

Corinne Petit-Frere³

et al.

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Cited by 5 publications

References 19 publications

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Pharmacokinetics and Safety of Intravenous Candidate Biosimilar CT‐P47 and Reference Tocilizumab: A Randomized, Double‐Blind, Phase 1 Study

Haranaka,

Eto,

Tanaka

et al. 2024

The Journal of Clinical Pharma

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CT‐P47 is a candidate biosimilar of tocilizumab. This 12‐week, randomized, double‐blind, parallel‐design, phase 1 study aimed to demonstrate pharmacokinetic (PK) equivalence of CT‐P47 and reference tocilizumab. Participants were healthy Japanese adults aged 18–55 years. Participants were randomized (1:1:1) to receive a single intravenous dose (8 mg/kg) of CT‐P47, EU‐approved tocilizumab (EU‐tocilizumab), or US‐licensed tocilizumab (US‐tocilizumab). Primary PK endpoints were area under the concentration–time curve (AUC) from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum serum concentration. Additional PK variables, safety, and immunogenicity were evaluated. The study was conducted from January 20 to May 26, 2023, in three centers in Japan. In total, 133 male participants were randomized (n = 45 to CT‐P47, n = 44 to EU‐tocilizumab, and n = 44 to US‐tocilizumab). For all primary PK variables, 90% confidence intervals of the ratio of geometric least squares means were within the predefined equivalence margin of 0.80‐1.25. Secondary PK variables were similar across groups. The most common treatment‐emergent adverse event (TEAE) was neutrophil count decreased, occurring in 15 (33.3%), 13 (30.2%), and 12 (27.3%) participants in the CT‐P47, EU‐tocilizumab, and US‐tocilizumab groups, respectively. There were no serious TEAEs, deaths, or study drug discontinuations due to TEAEs. Few participants were anti‐drug antibody (ADA)‐ or neutralizing antibody (NAb)‐positive. At the end of study, four (8.9%), one (2.3%), and two (4.5%) participants in the CT‐P47, EU‐tocilizumab, and US‐tocilizumab groups, respectively, were ADA‐positive; two (4.4%), zero (0%), and one (2.3%) in the respective groups were NAb‐positive. CT‐P47 demonstrated PK equivalence and comparable safety to EU‐ and US‐tocilizumab.

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Pharmacokinetics and Safety of Intravenous Candidate Biosimilar CT‐P47 and Reference Tocilizumab: A Randomized, Double‐Blind, Phase 1 Study

Haranaka,

Eto,

Tanaka

et al. 2024

The Journal of Clinical Pharma

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Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What Have We Learned?

Avci,

Feist,

Burmester

2023

BioDrugs

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The use of different pathways in the treatment of rheumatoid arthritis has led to a significant decrease in the number of treatment-resistant patients. In this context, interleukin (IL)-6 inhibition has filled an important gap in rheumatoid arthritis treatment with its effectiveness and safety in both monotherapy and combinations. The process of IL-6 inhibition initiated with IL-6 receptor blockers has prompted questions regarding the potential impact and safety of different inhibitions of this pathway, such as the direct blockade of IL-6. Following the termination of the development of sirukumab because of mortality data in early studies, the investigation of olokizumab, which targets a different region of the IL-6 cytokine, has renewed the hope in this area and the safety concerns have been largely alleviated by the open-label extension data. In addition, the efficacy and safety of tocilizumab and sarilumab have led to a rapid investigation of biosimilars and new potent IL-6 receptor blockers. A comprehensive understanding of mechanisms of this pathway with further long-term clinical data and basic research may provide a decisive impact on selecting the appropriate mechanism as the first choice in personalized treatments.

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Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study

Kim

Shin

et al. 2023

Expert Opinion on Investigational Drugs

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Pharmacokinetics of a proposed tocilizumab biosimilar (MSB11456) versus US-licensed tocilizumab: results of a randomized, double-blind, single-intravenous dose study in healthy adults

Cited by 5 publications

References 19 publications

Pharmacokinetics and Safety of Intravenous Candidate Biosimilar CT‐P47 and Reference Tocilizumab: A Randomized, Double‐Blind, Phase 1 Study

Pharmacokinetics and Safety of Intravenous Candidate Biosimilar CT‐P47 and Reference Tocilizumab: A Randomized, Double‐Blind, Phase 1 Study

Targeting IL-6 or IL-6 Receptor in Rheumatoid Arthritis: What Have We Learned?

Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study

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