Trastuzumab biosimilar is under clinical development by Prestige BioPharma and currently in Phase III for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer). According to GlobalData, Phase III drugs for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Trastuzumab 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.

Trastuzumab biosimilar overview

Trastuzumab biosimilar is under development for the treatment of HER positive breast cancer and gastric cancer or gastroesophageal juction adenocarcinomas. The drug candidate is administered through intravenous route as a drip. Trastuzumab is a recombinant IgG1 kappa, humanized monoclonal antibody acts by targeting cells expressing HER2.

Prestige BioPharma overview

Prestige BioPharma (PBP) is a biopharmaceutical company that discovers and develops biosimilars and antibody therapeutics for oncology and immune disorders. The company pipeline includes HD201, HD204 and PBP1502 for the indications of breast cancer, gastric cancer, solid tumors and arthritis. PBP other pipeline includes PBP1510, PBP1710, IDC001, IDC005, IDC007 and IDC008 for the indication of pancreatic cancer, ovarian cancer and critical immune disorders. The company also provides vaccines and PAUF-detecting diagnostic kits. It operates its manufacturing facility and research center in Singapore and South Korea. PBP is headquartered in Singapore.

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

This content was updated on 7 February 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.