On 5 June 2026, Shanghai Henlius Biotech announced that the first US patient has been dosed in its international Phase 1 clinical trial of HLX17, biosimilar to MSD’s Keytruda® (pembrolizumab). The study had previously completed first patient dosing in China.
The Phase 1 study, initiated in September 2025, is designed to evaluate the pharmacokinetic (PK) profile, efficacy, safety and immunogenicity of HLX17 versus US-sourced Keytruda® in patients with multiple resected solid tumours, including non‑small cell lung cancer, melanoma, or renal cell carcinoma. Primary completion of the study is expected in April 2027.
A second study (integrated Ph 1/3) was initiated by Henlius in April 2025 to evaluate the efficacy, safety PK profile and immunogenicity of HLX17 versus Keytruda® in the first-line treatment of advanced nsNSCLC.
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 appears to be the front runner, having demonstrated pharmacokinetic bioequivalence with Keytruda® in its “Dahlia” study (reported in February 2026). Formycon’s US commercialisation partner, Zydus, has 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 Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, 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.