During its Q3 FY26 Earnings Call on 10 February 2026, Zydus Lifesciences indicated that it is hoping to be the first to file a Biologics Licence Application in the US for a pembrolizumab biosimilar and may potentially be first to launch in the US, subject to regulatory approvals.
The optimism comes after Zydus entered into an exclusive licensing and supply agreement with Formycon in December 2025 for the commercialisation of Formycon’s FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab), in the US and Canada. According to Zydus, Formycon is “the furthest ahead in terms of the clinical development and FDA guidance” in relation to biosimilar pembrolizumab.
Formycon commenced an integrated Ph1/3 study in June 2024 to demonstrate PK similarity of FYB206 with Keytruda® in patients with Stage IIB/IIC or Stage III melanoma. On 10 July 2025, Formycon announced that it had completed patient enrolment. Formycon expects results to be available in Q1 2026. Formycon had originally intended to conduct a parallel Phase 3 trial to compare the safety and efficacy of FYB206 with Keytruda® in NSCLC. However, in February 2025, Formycon announced the premature termination of the Phase 3 trial on the basis that the trial was not necessary to obtain US approval of FYB206.
Other pembrolizumab biosimilars in clinical trials include Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024, initiated January 2025), Amgen’s ABP 234 (Ph 3 in early stage nsNSCLC initiated May 2024, Ph 3 in advanced or metastatic nsNSCLC commenced September 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024), Sandoz’s GME751 (Ph 1 commenced in May 2024), Henlius’ HLX17 (approval for clinical trial received September 2024), and mAbxience’s MB12 (Ph 3 study commenced December 2024).