Samsung Bioepis announced that it has commenced a Ph 1 clinical trial for SB27, biosimilar to Merck’s Keytruda® (pembrolizumab). The study will compare the pharmacokinetics, efficacy, safety, and immunogenicity of SB27 with EU and US-sourced Keytruda®, in patients with stage II-IIIA non-small cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy. This announcement follows the report on 15 November 2023 that Samsung Bioepis had received approval from the Ministry of Food and Drug Safety for a Ph I clinical trial of SB27.
Each of Formycon, Xbrane and Celltrion announced (on 19 September 2022, 13 December 2021 and 14 February 2018 respectively) that they have pembrolizumab biosimilars in development. A pembrolizumab biosimilar (BCD-201) is currently the subject of clinical trials commenced by Biocad in July 2022. Sandoz is expecting to commence pembrolizumab biosimilar clinical trials in 2024.