Denosumab biosimilar is under clinical development by Alvotech and currently in Phase I for Autoimmune Disorders. According to GlobalData, Phase I drugs for Autoimmune Disorders have a 74% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Denosumab 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.

Denosumab biosimilar overview

AVT-03 is under development for the treatment of osteoporosis, post menopausal osteoporosis, unspecified cancer and autoimmune disorder. The therapeutic candidate is a biosimilar of denosumab. It is administered by subcutaneous route. It acts by targeting receptor activator of nuclear factor kappa-B ligand RANKL).

Alvotech overview

Alvotech is a biopharmaceutical company that focuses on the development and manufacturing of biosimilar medicines. The company’s purpose is to improve the health and quality of life of patients by improving access to proven treatments for various diseases. Its current pipeline contains eight biosimilar candidates for the treatment of autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. The company also offers research and development services. It has operations in Luxemburg, Switzerland, Germany, Australia and Iceland. Alvotech is headquartered in Luxemburg.

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

This content was updated on 10 June 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.