Adalimumab biosimilar is under clinical development by Enzene Biosciences and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Adalimumab biosimilar’s likelihood of approval (LoA) and phase transition for Ankylosing Spondylitis (Bekhterev’s Disease) took place on 16 Feb 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Adalimumab biosimilar Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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.

Quick View Adalimumab biosimilar LOA Data

Report Segments
  • Biosimilar
Drug Name
  • Adalimumab biosimilar
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Immunology
  • Musculoskeletal Disorders
Key Developers
Highest Development Stage
  • Phase III

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.