Five days after Bio-Thera announced the start of its integrated Phase I/III trials for BAT3306 (pembrolizumab), on 30 July 2024, Formycon announced enrolment of the first patient in its Phase III trial for FYB206 (pembrolizumab), biosimilar to MSD’s Keytruda®. The “Lotus” trial will compare the safety and efficacy of FYB206 with Keytruda® in patients with non-small cell lung cancer (NSCLC) in Eastern Europe and Southeast Asia.
Formycon commenced a Phase I trial for FY206 in malignant melanoma patients in June 2024.
FYB206 and BAT3306 join a raft of other pembrolizumab biosimilars in clinical trials including Amgen’s ABP 234 (Ph 3 study in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 study for metastatic nsNSCLC 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 joint pembrolizumab biosimilar development.