On 10 July 2025, Formycon announced that it has completed patient enrolment for its clinical study, “Dahlia”, which is comparing the pharmacokinetics, safety and tolerability of FYB206 (pembrolizumab) with MSD’s Keytruda® in malignant melanoma. The study was commenced in June 2024 and has now enrolled a total of 96 participants.
Formycon had originally intended to conduct a parallel Phase 3 trial (“Lotus”) to compare the safety and efficacy of FYB206 with Keytruda® in non-small cell lung cancer (NSCLC). However, in February 2025, Formycon announced the premature termination of the Phase 3 trial following communications with the US FDA and concluding that the trial was not necessary to obtain US approval of FYB206.
Formycon expects results of the study to be available in Q1 2026, with the earliest market entry of FYB206 being in 2029 for the US and after 2030 for the EU.
There are a number of other pembrolizumab biosimilars in clinical trials, including Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024), Bio-Thera’s BAT3306 (Ph 1/3 in nsNSCLC commenced in July 2024), Amgen’s ABP 234 (Ph 3 in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 commenced in May 2024).
In September 2024, Shanghai Henlius Biotech received approval in China for a clinical trial of its pembrolizumab biosimilar, HLX17 and, in June 2025, Alvotech and Dr Reddy’s announced that they entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a pembrolizumab biosimilar.