Ustekinumab biosimilar is under clinical development by Formycon and currently in Phase I for Crohn’s Disease (Regional Enteritis). According to GlobalData, Phase I drugs for Crohn’s Disease (Regional Enteritis) have an 81% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Ustekinumab 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.

Ustekinumab biosimilar overview

Ustekinumab biosimilar (FYB-202) is under development for the treatment of Crohn's disease, plaque psoriasis, ulcerative colitis and psoriatic arthritis. It is administered through intravenous and subcutaneous routes. The drug candidate acts by targeting interleukin 12 subunit beta and interleukin 23 subunit alpha.

Formycon overview

Formycon is a developer and manufacturer of pharmaceutical and biopharmaceutical products to treat chronic diseases, ophthalmology and immunology indications. The company pipeline products include FYB201, a ranibizumab biosimilar drug targeting neovascular (wet) age-related macular degeneration (nAMD) and other eye diseases, FYB202 drug for the treatment of psoriasis and other inflammatory diseases, FYB203, a biosimilar candidate for Eylea, used to treat neovascular age-related macular degeneration (nAMD) and other eye diseases and FYB207, an antiviral drug to treat COVID-19. Formycon’s out-licensing partners include Bioeq AG, Klinge Biopharma GmbH and Aristo Pharma GmbH. Formycon is headquartered in Martinsried, Bayern, Germany.

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

This content was updated on 22 April 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

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.