On 30 April 2025, when announcing its Q1/2025 financial results, Sandoz indicated that it will be “minimising” the Phase 3 trial of its biosimilar to MSD’s Keytruda® (pembrolizumab) in patients with untreated metastatic non-squamous non-small cell lung cancer. The decision reportedly follows communications between Sandoz and the US FDA and the EMA’s April 2025 reflection paper considering the possible waiver of comparative efficacy study requirements for biosimilars.
According to Sandoz, it will continue its Phase 1 trial as planned. The Phase 1 trial is investigating the pharmacokinetic similarity and efficacy, safety, and immunogenicity of Sandoz’s pembrolizumab biosimilar, GME751, compared with Keytruda® (pembrolizumab) in subjects with resected advanced melanoma requiring adjuvant treatment with pembrolizumab.
This follows a similar announcement by Formycon in February 2025 regarding the premature termination of its “Lotus” Phase 3 trial of FYB206, biosimilar to Keytruda®. According to Formycon, following “intensive scientific dialogue” with the US FDA, it concluded that the Phase 3 study was no longer necessary for the development and US approval of FYB206. Instead, Formycon proposes to rely on data from its ongoing Phase 1 trial (“Dahlia”), combined with “a comprehensive analytical program”.