Denosumab biosimilar is under clinical development by Alvotech and currently in Phase III for Post Menopausal Osteoporosis. According to GlobalData, Phase III drugs for Post Menopausal Osteoporosis have an 83% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. 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 and unspecified cancer. 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 focused on 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, among others. It also offer research and development services. Alvotech work in partnerships and collaborations with other pharmaceutical companies and research universities which offering manufacturing, regulatory management and license agreements for its biosimilar assets. It has operations in Luxemburg, Switzerland, Germany 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 2 September 2023

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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.