On 10 August 2026, Samsung Bioepis announced that it has applied to Korea’s Ministry of Food and Drug Safety for approval of SB27, biosimilar to MSD’s Keytruda® (pembrolizumab). According to Samsung Bioepis, this application puts it ahead of competitor pembrolizumab biosimilars in the Korean product approval process.
Samsung Bioepis announced positive results from global phase 1 and 3 clinical trials for SB27 on 29 June 2026, confirming its equivalence with Keytruda®. At the time, Samsung Bioepis said it was the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results. The phase 1 and phase 3 trials were commenced in 2024, in an “overlap strategy” designed to accelerate SB27 development, with the studies expected to be completed by the end of 2026.
Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).
There are multiple pembrolizumab biosimilars in development. Formycon’s FYB206 demonstrated pharmacokinetic bioequivalence with Keytruda® in the Phase 1 “Dahlia” study (reported in February 2026). Formycon’s US commercialisation partner, Zydus, has previously expressed optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab. Formycon has also announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region and Lotus for the Asia-Pacific.
Other companies with pembrolizumab biosimilars in clinical trials include Amgen, mAbxience, Sandoz, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene. Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.