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 69% 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 biopharmaceutical company that specializes in researching and developing novel therapeutics. It primarily focuses on the treatment of cancer, autoimmune, cardiovascular and eye diseases, and other severe unmet medical needs. The company offers products that include qletli, pobevcy, tofidence, and betagrin. Its pipeline products include humanized monoclonal antibodies and peptide drugs such as BAT8001, BAT8003, BAT1306, BAT2094, and BAT4306F. Bio-Thera’s products are used in the treatment of various diseases, with applications in the medical and healthcare industries. The company also develops biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. It operates in China and the US. 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 12 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.