Adalimumab biosimilar is under clinical development by Enzene Biosciences and currently in Phase III for Ankylosing Spondylitis (Bekhterev’s Disease). According to GlobalData, Phase III drugs for Ankylosing Spondylitis (Bekhterev’s Disease) have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Adalimumab 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.

Adalimumab biosimilar overview

Adalimumab biosimilar (ENZ-129) is under development for the treatment of rheumatoid arthritis and ankylosing spondylitis (AS). The drug candidate is administered through subcutaneous route. It acts by targeting tumor necrosis factor (TNF)–alpha. The drug candidate is based on expression vector technology and ClonePix technology.

Enzene Biosciences overview

Enzene Biosciences a subsidiary of Alkem Laboratories Ltd is a biotechnology company that supports the development of drug discovery and manufacturing initiatives. The company has biosimilars under development in the therapeutic areas of metabolism, oncology, hematology, ophthalmology, allergy, rheumatoid arthritis. Enzene Biosciences also develops generics targeting the therapeutic area of oncology. The company offers technology platforms in the fields of molecular biology, protein expression, immunology, bio-analytics, fermentation technology and peptide synthesis. Enzene Biosciences conducts research on advanced analytical technologies, peptide synthesis, bioanalytical sciences, purification process development and drug product development. The company is also developing regenerative medicines. Enzene Biosciences is headquartered in Pune, Maharashtra, India.

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


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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.