INCHEON, South Korea, June 29, 2026
Samsung Bioepis Co., Ltd. has announced positive preliminary results from both its Phase 1 and Phase 3 clinical studies evaluating SB27, the company’s proposed biosimilar to Keytruda® (pembrolizumab). The studies successfully achieved their primary endpoints, demonstrating pharmacokinetic (PK) equivalence in the Phase 1 trial and equivalent objective response rate (ORR) at Week 24 in the Phase 3 trial. These encouraging topline findings represent an important milestone in Samsung Bioepis’ oncology biosimilar development program and reinforce the company’s leadership in developing high-quality biologic medicines designed to expand patient access to advanced cancer therapies. The company expects both studies to be completed during 2026, supporting future regulatory submissions aimed at bringing an affordable biosimilar alternative to one of the world’s most widely prescribed immune checkpoint inhibitors used in multiple cancer indications.
Clinical Studies Confirm Biosimilar Equivalence to Keytruda
The randomized, double-blind, multicenter Phase 1 clinical trial evaluated the pharmacokinetics, efficacy, safety, and immunogenicity of SB27 compared with both European Union-sourced and United States-sourced Keytruda in patients with Stage II or IIIA non-small cell lung cancer (NSCLC) following complete surgical resection and platinum-based chemotherapy. A total of 163 participants received treatment every three weeks, with pharmacokinetic analysis demonstrating that drug exposure measured by Area Under the Curve (AUC) met all predefined bioequivalence criteria.
In parallel, the Phase 3 randomized, double-blind clinical trial enrolled 555 patients with metastatic non-squamous NSCLC, comparing SB27 directly with Keytruda in combination with pemetrexed and carboplatin chemotherapy. The study successfully demonstrated equivalent objective response rates at Week 24, with the observed 90% confidence interval fully contained within the predefined equivalence margin, confirming comparable therapeutic performance between the biosimilar candidate and the reference biologic. Investigators also reported comparable safety, pharmacokinetic, and immunogenicity profiles, further supporting SB27’s biosimilar profile.
Biosimilar Development Supports Broader Access to Oncology Treatments
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Pembrolizumab has become one of the most widely used PD-1 immune checkpoint inhibitors globally, serving as a standard treatment across numerous malignancies including melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and several additional solid tumors. As demand for biologic cancer therapies continues to increase worldwide, the development of high-quality biosimilars plays an increasingly important role in improving healthcare affordability while expanding patient access to life-saving treatments. Samsung Bioepis emphasized that the successful preliminary results reflect the company’s extensive experience in biosimilar research, manufacturing excellence, and rigorous quality management systems that have supported multiple successful global biosimilar programs. The company continues to strengthen a diversified pipeline spanning oncology, immunology, ophthalmology, hematology, nephrology, endocrinology, and neurology, reinforcing its long-term commitment to advancing accessible biologic medicines for patients worldwide.
The positive Phase 1 and Phase 3 SB27 results represent another important milestone in the rapidly growing global biosimilars market, demonstrating Samsung Bioepis’ continued ability to develop scientifically robust alternatives to complex biologic therapies while supporting healthcare sustainability. If successfully approved by regulatory authorities, SB27 has the potential to broaden patient access to pembrolizumab-based immunotherapy, improve treatment affordability, and strengthen competition within the oncology biologics market, further advancing precision cancer care while helping healthcare systems manage rising biologic treatment costs across multiple cancer indications.
Source: Samsung Bioepis press release
