Agalsidase beta biosimilar is under clinical development by Biosidus and currently in Phase III for Fabry Disease. According to GlobalData, Phase III drugs for Fabry Disease have an 80% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Agalsidase beta 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.

Agalsidase beta biosimilar overview

Agalsidase beta (alpha-galactosidase) biosimilar is under development for the treatment of Fabry’s disease. The drug candidate is administered through intravenous route. It acts by targeting alpha-galactosidase A. The drug candidate is developed based on transgenic animals technology.

Biosidus overview

Biosidus operates as a biotechnology company that develops, manufactures and distributes biosimilars. The company provides products such as epoetin, filgrastim, interferon beta 1a, somatropin, interferon alpha 2a, interferon alpha 2b, intestinal probiotic and lenograstim, among others. It has developed a patent protected technological platform based on the generation of genetically modified bovines by mammal cloning techniques. Biosidus products are used in the treatment of anemia, neutropenia, relapsing recurrent multiple sclerosis, hepatitis B and C, AIDS-related kaposi’s sarcoma, certain cancers, and others. The company also concentrates on transgenic animals and gene therapy applied to the management of central and peripheral vascular disease. Biosidus is headquartered in Buenos Aires, Argentina.

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

This content was updated on 22 April 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.