Pembrolizumab biosimilar is under clinical development by Samsung Bioepis and currently in Phase III for Non-Small Cell Lung Cancer. According to GlobalData, Phase III drugs for Non-Small Cell Lung Cancer have a 46% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. 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 biosimilar (SB-27) is under development for the treatment of stage II-IIIA non-small cell lung cancer (NSCLC). The drug candidate is administered through intravenous (IV) route. It acts by targeting programmed cell death protein (PD1).

Samsung Bioepis overview

Samsung Bioepis, a subsidiary of Samsung Biologics Co Ltd, is a biopharmaceutical company. The company develops biosimilar products for immunology, oncology, ophthalmology, hematology and endocrinology indications. It offers biological drugs for the treatment of Crohn’s disease, ulcerative colitis, psoriasis, cancer and arthritis. The company is investigating SB12, an Eculizumab biosimilar targeting paroxysmal nocturnal hemoglobinuria; SB15, an Aflibercept biosimilar medicine against neovascular age-related macular degeneration; SB16, a denosumab biosimilar for the treatment of endocrinology disorders. Samsung Bioepis is also evaluating SB17, a Ustekinumab molecule against moderate to severe plaque psoriasis; and SB26 biosimilar to treat gastroenterology indications. Samsung Bioepis is headquartered in Incheon, Seoul, South Korea.

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

This content was updated on 16 July 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.