On 26 September 2025, Shanghai Henlius announced that the first patient has been dosed in its phase 1 multicentre clinical trial for HLX17, biosimilar to MSD’s Keytruda® (pembrolizumab).
The trial is being conducted in China to evaluate the pharmacokinetic profile, efficacy, safety and immmunogencity of HLX17 in comparison to US-sourced Keytruda® in patients with multiple-resected solid tumours (including non-small cell lung cancer, melanoma, or renal cell carcinoma).
A number of pembrolizumab biosimilars are currently in clinical trials, including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Formycon, Celltrion, Bio-Thera and BioNTech. Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®. Bioéticos claims to have launched the first pembrolizumab biosimilar in Paraguay in August 2025 under the name Pembrolizumab Bioéticos.