On 13 June 2024, Formycon announced that it has commenced Phase 1 trials for its FYB206, biosimilar to Merck’s (MSD) blockbuster Keytruda® (pembrolizumab), in malignant melanoma. A parallel Phase 3 trial, yet to commence, will compare the safety and efficacy of FYB206 with Keytruda® in non-small cell lung cancer (NSCLC). Formycon says it expects the earliest market entry for FYB206 to be in 2029 in the US (after Keytruda’s market exclusivity expiry) and in 2030 in Europe.
Other pembrolizumab biosimilars in clinical trials are Amgen’s ABP 234 (Ph 3 study in non-squamous NSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 study for metastatic non-squamous NSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 and 3 clinical trials commenced in April/May 2024). In March 2024, Korea Biomedical Review reported that Rophibio entered into an agreement with US biotech Avantor in relation to the development of a pembrolizumab biosimilar. Xbrane and Celltrion have also each previously announced a joint pembrolizumab biosimilar development.