On 5 September 2025, the World Health Organisation (WHO) announced that it has updated its Model List of Essential Medicines (EML) to include pembrolizumab (including “quality assured biosimilars”) as a first-line monotherapy for metastatic cervical cancer, metastatic colorectal cancer, and metastatic non-small cell lung cancer (NSCLC). Atezolizumab and cemiplimab (including “quality assured biosimilars”) are listed as therapeutic alternatives to pembrolizumab for metastatic NSCLC.
The WHO Model Lists are updated every two years and are intended as a guide for countries or regional authorities to adopt or adapt in accordance with local priorities and treatment guidelines for the development and updating of national essential medicines lists. Essential medicines are those considered to satisfy the priority health care needs of a population.
Amongst the biopharmaceuticals added to the Model List this year, ustekinumab and adalimumab (with certolizumab pegol, etanercept and infliximab as therapeutic alternatives) were also added to a complementary list (medicines for which specialised monitoring, diagnostics or care are required) for the treatment of adults and children with moderate-to-severe psoriasis. Emicizumab has been included on the Model List for Haemophilia A.
MSD’s Keytruda® (pembrolizumab) has been approved in multiple jurisdictions for multiple cancer-related indications. In August 2025, Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay, under the name Pembrolizumab Bioéticos. A number of pembrolizumab biosimilars are currently in clinical trials, including those of Samsung Bioepis, Amgen, mAbxience, Sandoz, Formycon, Celltrion, Shanghai Henlius, 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®.
No biosimilars to Roche’s Tecentriq® (atezolizumab) or Regeneron and Sanofi’s Libtayo® (cemiplimab) have been approved to date.