On 24 September 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has instructed Intas Pharmaceuticals to submit a revised protocol for its proposed biosimilar pembrolizumab Phase I/III clinical trial.
Intas’ proposed clinical trial is intended to be a multicentre study comparing the efficacy, safety, pharmacokinetics and immunogenicity of INTP58 with MSD’s Keytruda® (pembrolizumab), both administered with chemotherapy, in first line treatment of locally advanced or metastatic squamous or non-squamous non-small cell lung cancer. The SEC raised a number of issues in relation to the trial protocol, including that the study duration should be increased, and the dose of chemotherapy (paclitaxel) should be reduced.
There are a number of pembrolizumab biosimilars already in clinical trials, including those of Samsung Bioepis, Amgen, mAbxience, Sandoz, Formycon, Celltrion, Shanghai Henlius, Bio-Thera and BioNTech. Alvotech and Dr Reddy’s entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®. Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay in August 2025, under the name Pembrolizumab Bioéticos.