Pembrolizumab biosimilar is under clinical development by Biocad and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% 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 (Pembroria) is an antineoplastic immunomodulating agent. Pembroria is formulated as concentrate solution for intravenous route of administration. Pembroria is indicated for the treatment of  cervical cancer, colorectal cancer, esophageal cancer, head and neck cancer, hodgkin lymphoma (B-cell hodgkin lymphoma), malignant neoplasms, metastatic melanoma, small-cell lung cancer, transitional cell carcinoma (urothelial cell carcinoma).

Pembrolizumab biosimilar is under development for the treatment of solid tumors. It acts by targeting programmed cell death protein 1 (PD1). It is administered through parenteral route.

Biocad overview

JSC Biocad (Biocad) is a biotechnology company that conducts research and development services. The company develops, manufactures, and distributes generic pharmaceutical products. Its products portfolio includes rituximab, bevacizumab, trastuzumab, prolgolimab, levilimab, netakimab and eculizumab. Biocad develops products in the form of suppositories, spray, and drops. The compay provides products under the brands Avegra, Herticad, Gerticad, Forteka, Extimia and Leucostim. It manufactures products in the therapeutic areas such as oncology, rare disease, autoimmune diseases, and infectious diseases. The company’s R&D centers are located in Lyubuchany, Neudorf and Frontovaya. It operates in Brazil, China, Russia, the UAE and Vietnam. Biocad is headquartered in Saint-Petersburg, Russia.

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


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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.