FYB206

FYB206 is a proposed biosimilar to pembrolizumab (marketed as Keytruda), a recombinant humanized monoclonal antibody of the IgG4 subclass that targets programmed cell death protein 1 (PD-1). Pembrolizumab blocks the interaction between PD-1 and its ligands (PD-L1 and PD-L2), thereby enhancing T-cell mediated immune responses against tumor cells. Unlike some other antibodies, it does not engage Fc receptors or activate complement pathways and thus lacks antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC). FYB206 is being developed by Formycon as an affordable alternative for cancer immunotherapy in indications where pembrolizumab is approved or under investigation. Clinical development has included Phase 1 trials in malignant melanoma and Phase 3 trials in non-small cell lung cancer; however, the Phase 3 trial was terminated early following discussions with regulatory authorities regarding approval pathways for biosimilars[1][5][7].

Brand names

Pembroria

Other names

pembrolizumabKeytrudaFYB206FYB-206FYB 206