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 (Tuznue ) is a recombinant IgG1 kappa, humanized monoclonal antibody. It is formulated as lyophilized powder for concentrate for solution for intravenous route of administration. Tuznue is indicated for the treatment of breast cancer, metastatic breast cancer HER2 (Human Epidermal growth factor Receptor 2 protein)-positive metastatic breast cancer patients, early breast cancer, metastatic gastric cancer, adenocarcinoma of gastro-oesophageal function.
Trastuzumab biosimilar is under development for the treatment of HER positive breast cancer and 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. It was under development for the treatment of gastric cancer.
Prestige BioPharma overview
Prestige BioPharma is a biopharmaceutical company specializing in the development of biosimilars and novel antibody therapeutics. The company’s offers research and development of biosimilars and first-in-class antibody drugs, as well as vaccines for infectious diseases. Its pipeline products include HD201, HD201, PBP2101, PBP2102, PBP1701, IDC2405 treats oncology; PBP1502, PBP1603, IDC2401, IDC2403, IDC2404 for Immunology; PBP1601, IDC2402 treats endocrinology and others. The company’s therapeutic areas include oncology, immunology, endocrinology, ophthalmology; hematology, and others. It collaborates with major pharmaceutical partners. The company operates 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.
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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.
