On 13 October 2026, Formycon and Zydus Lifesciences announced that the FDA has accepted for review their Biologics Licence Application for FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab). This is the first publicly announced BLA acceptance for a Keytruda® biosimilar in the US.
Zydus had previously expressed optimism that it was well placed to file the first BLA in the US for biosimilar pembrolizumab, following Formycon’s announcement of successful Phase 1 results for FYB206 in February 2026 (the “Dahlia” pharmacokinetic study). The companies completed clinical development of FYB206 in July 2026 and are relying on a streamlined clinical trial pathway (without a comparative Phase 3 efficacy trial) to accelerate and support the approval of FYB206.
Based on a 12 month FDA review period for the BLA, and a BLA filing date in Q3/2026, a decision on FYB206 is expected in Q3/2027. A regulatory dossier for FYB206 has also been submitted to Health Canada for approval.
Zydus is commercialising FYB206 in the US and Canada under an exclusive licensing and supply agreement with Formycon entered into in December 2025. Formycon has entered into separate agreements for commercialisation of FYB206 with MS Pharma for MENA and Lotus for the Asia-Pacific.
Applications for approval of pembrolizumab biosimilars were filed in Korea by Samsung Bioepis (SB27) and Celltrion (CT-P51) in August 2026. Two months earlier, in June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results. Amgen also 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.