Ustekinumab biosimilar is under clinical development by Biocon and currently in Phase III for Crohn’s Disease (Regional Enteritis). According to GlobalData, Phase III drugs for Crohn’s Disease (Regional Enteritis) have a 64% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. 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 (Bmab 1200) is under development for the treatment of Crohn's disease, plaque psoriasis and psoriatic arthritis. The drug candidate is monoclonal antibody that acts by targeting interleukin 12 subunit beta and interleukin 23 subunit alpha. The drug candidate is administered through subcutaneous route. 

Biocon overview

Biocon is a biopharmaceutical company that focuses on the research and development of therapies for the treatment of chronic conditions such as cancer, diabetes and autoimmune diseases. It offers a range of active pharmaceutical ingredients (APIs), branded formulations, complex biologics and biosimilars including monoclonal antibodies (MAbs), rh-Insulin, and insulin analogs. The company also provides services including contract manufacturing, drug licensing, research, development and manufacturing of small and large molecules for biotechnology and pharmaceutical companies across the world. It has a manufacturing facility and R&D center at BioXcell, Malaysia. It operates overseas offices in the UK, Ireland, the US, Switzerland, the UAE, and Malaysia. Biocon is headquartered in Bangalore, Karnataka, India.

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

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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.