By: IPP Bureau
Last updated : May 06, 2026 6:57 am
The proposed biosimilar to Keytruda demonstrated pharmacokinetic bioequivalence in a multicountry Phase 1 study involving non-small cell lung cancer patients
Samsung Bioepis Co., Ltd. has announced that its phase 1 clinical study evaluating SB27, a proposed biosimilar to Keytruda (pembrolizumab), successfully met its primary pharmacokinetic (PK) endpoints.
The randomized, double-blind, three-arm, parallel-group, multicenter study demonstrated pharmacokinetic bioequivalence between SB27 and the reference product Keytruda. Initiated in January 2024, the Phase 1 study is being conducted across four countries and is expected to conclude by November 2026.
The study evaluated the pharmacokinetics, efficacy, safety, and immunogenicity of SB27 compared with EU-sourced and US-sourced Keytruda in patients with stage II or IIIA non-small cell lung cancer (NSCLC) who had undergone complete surgical resection followed by adjuvant platinum-based chemotherapy.
A total of 163 participants were randomized to receive SB27, EU-sourced Keytruda, or US-sourced Keytruda every three weeks for up to 18 cycles over approximately 51 weeks.
Preliminary pharmacokinetic analysis showed that drug exposure levels, measured through Area Under the Curve (AUC), met the predefined equivalence criteria.
Commenting on the development, Donghoon Shin said the positive topline Phase 1 results reinforce the company’s scientific expertise and leadership in biosimilar development. He added that Samsung Bioepis remains on track to complete both its Phase 1 and Phase 3 studies for SB27 within 2026.
The company’s ongoing Phase 3 study, initiated in March 2024, is evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of SB27 compared to Keytruda in patients with metastatic non-squamous NSCLC.