On 16 October 2024, Formycon announced that results of a comparative analytical evaluation of its FYB206, published in Drugs in R&D, showed FYB206 to be structurally and functionally “highly similar” to MSD’s Keytruda® (pembrolizumab).
FYB206 is currently being evaluated in a phase 1 trial (“Dahlia”) to compare the pharmacokinetics, safety and tolerability of FYB206 with Keytruda® in malignant melanoma (commenced June 2024) and a phase 3 trial (“Lotus”) to compare the efficacy and safety of FYB206 with Keytruda® in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC) (commenced 30 July 2024).
A number of pembrolizumab biosimilars have entered clinical trials this year, 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 25 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 and 3 commenced in April/May 2024). In September 2024, Shanghai Henlius Biotech received approval in China for a clinical trial of its pembrolizumab biosimilar, HLX17.