On 30 October 2026, Samsung Bioepis announced that it has applied to the FDA for marketing authorisation of SB27, biosimilar to MSD’s Keytruda® (pembrolizumab), across 18 cancer indications.
This is the second reported US filing for a pembrolizumab biosimilar following Formycon/Zydus’ Biologics Licence Application for FYB206. Formycon/Zydus announced on 13 October 2026 that the FDA had accepted for review their FYB206 BLA.
In June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results. In comparison, Formycon is relying on a streamlined clinical trial pathway (without a comparative Phase 3 efficacy trial) to accelerate and support the approval of its pembrolizumab biosimilar FYB206.
Applications for approval of pembrolizumab biosimilars were filed in Korea by Samsung Bioepis (SB27) and Celltrion (CT-P51) in August 2026. Amgen confirmed on 15 September 2026 that its Keytruda® biosimilar has successfully completed clinical trials with an FDA submission likely later in 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). Pembrolizumab biosimilars are also in clinical trials including by mAbxience, Sandoz, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.