On 25 February 2026, Formycon and Zydus announced positive results from the phase 1 pharmacokinetic study (“Dahlia”) for FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab). The study, commenced in June 2024, is reported to have met its primary objective and demonstrated bioequivalence of FYB206 and Keytruda®.
The study is part of a streamlined clinical strategy agreed by Formycon with the FDA in relation to FYB206. In February 2025, Formycon announced it would terminate a Phase 3 trial of FYB206, which commenced in June 2024 as it was no longer necessary for FDA approval. Instead, Formycon intends to rely on data from the “Dahlia” trial, combined with a comprehensive analytical program to support its regulatory applications, with the aim of making FYB206 available “as soon as possible after the exclusivity” of Keytruda® expires.
Zydus has the exclusive rights to commercialise FYB206 in the US and Canada under an agreement with Formycon announced in December 2025. Zydus is hoping to be the first to file a Biologics Licence Application for biosimilar pembrolizumab in the US. Formycon has also recently announced FYB206 commercialisation agreements with MS Pharma (for the MENA Region) and Lotus Pharmaceutical (for parts of Asia Pacific).
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 in clinical trials include Amgen’s ABP 234 (Ph 3 in early stage nsNSCLC initiated May 2024, Ph 3 in advanced or metastatic nsNSCLC commenced September 2024), Bio-Thera’s BAT3306 (integrated PhI/III trial commenced, Ph 3 terminated July 2025 due to regulatory developments), Celltrion’s CT-P51 (Ph 3 trial approved by FDA in August 2024, initiated January 2025), Sandoz’s GME751 (Ph 1 commenced in May 2024, estimated completion July 2026), mAbxience’s MB12 (Ph 3 study commenced December 2024, estimated completion June 2026), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024, expected completion September 2026) and Shanghai Henlius’ HLX17 (approval for clinical trial received September 2024). Biocon and Alvotech have pembrolizumab biosimilars in their pipelines.