Tocilizumab biosimilar is under clinical development by Fresenius Kabi SwissBioSim and currently in Pre-Registration for Rheumatoid Arthritis. According to GlobalData, Pre-Registration drugs for Rheumatoid Arthritis have a 92% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. GlobalData’s report assesses how Tocilizumab biosimilar’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Tocilizumab biosimilar overview

Tocilizumab (Tyenne) is a humanized monoclonal antibody, acts as immunosupressant preparation. It is formulated as concentrate solution for intravenous and subcutaneous route of administration. Tyenne is indicated for the treatment of the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX and the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more diseasemodifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists, coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation, active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids, juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older, who have responded inadequately to previous therapy with MTX and chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.

MSB-11456 is under development for the treatment of moderately to severely active rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis. It is an tocilizumab biosimilar. The drug candidate is administered through subcutaneous and intravenous routes. It acts by targeting interleukin 6 receptor.

It was also under development for systemic sclerosis and juvenile rheumatoid arthritis.

For a complete picture of Tocilizumab biosimilar’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 February 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.