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 73% 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.
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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 develops, manufactures and commercializes biosimilar medicines. The company’s pipeline immunology products include AVT02, AVT04, AVT05, AVT16 and AVT23 target respiratory diseases; AVT06 and AVT33 for ophthalmology and oncology; AVT03 for bone disease; AVT19, AVT28 and AVT41. Its biosimilars include HUMIRA, STELARA, XOLAIR, PROLIA, SIMPONI, ARIA, EYLEA, ENTYVIO and KEYTRUDA. The company operates in the US, Luxemburg, Switzerland, Canada and Australia, among others. Alvotech is headquartered in Luxemburg.
For a complete picture of Denosumab 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.
