Pembrolizumab biosimilar is under clinical development by Bio-Thera Solutions and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 70% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Pembrolizumab 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.

Pembrolizumab biosimilar overview

Pembrolizumab (BAT-3306) is under development for the treatment of solid tumor and non-squamous non-small cell lung cancer. It acts by targeting programmed cell death protein 1 (PD1) and is administered through intravenous route. It is being developed based on ADCC platform.

Bio-Thera Solutions overview

Bio-Thera Solutions (Bio-Thera) is a clinical-stage biopharmaceutical company that carries out the research and development and production of innovative drugs and biosimilars. The company’s pipeline products include humanized monoclonal antibodies and peptide drugs such as BAT8001, BAT8003, BAT1306, BAT2094, and BAT4306F. It also offers BAT1406, an adalimumab biosimilar; BAT1706, a bevacizumab biosimilar; BAT1806, a tocilizumab biosimilar; and BAT2506. The company develops its products and therapies for the treatment of indications such as cancer, autoimmune diseases, cardiovascular diseases, arthritis, Crohn’s disease, psoriasis, polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile idiopathic arthritis (SJIA). Bio-Thera is headquartered in Guangzhou, Guangdong, China.

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

This content was updated on 10 June 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.