{"entity":{"id":"idea-reg-pd1-biosimilar-advance-commitment","kind":"idea","name":"An advance market commitment for PD-1 biosimilars for lower-income countries","aka":[],"tldr":"Immunotherapy patents start expiring around 2028. Guaranteeing in advance to buy cheap copies for poorer countries would make sure manufacturers build the capacity.","summary":"Pembrolizumab and nivolumab lose their core patent protection in the largest markets from about 2028; biosimilar developers are targeting high-income markets first, and LMIC supply may lag by years as it did for trastuzumab. Gavi's pneumococcal advance market commitment showed that a guaranteed purchase at a ceiling price can accelerate manufacturing investment for poorer markets. The proposal is a donor- and government-backed commitment to buy a defined volume of WHO-prequalified PD-1 biosimilars for LMIC programmes at a ceiling price (for example under $500 per dose) from 2028, with WHO prequalification and pooled procurement handling quality and distribution.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Prices and value): Prasad, De Jesús & Mailankody, The high price of anticancer drugs: origins, implications, barriers, solutions (Nat Rev Clin Oncol 2017)","url":"https://doi.org/10.1038/nrclinonc.2017.31"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":["pd1"],"drugs":["pembrolizumab","nivolumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-drug-pricing","b-global-access"],"keyPapers":["paper-prasad-nat-rev-clin-oncol"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"The commitment leads to at least two prequalified PD-1 biosimilars being supplied to LMIC programmes within 18 months of patent expiry, at prices under a tenth of current high-income list prices, treating more than 100,000 additional patients a year within five years.","rationale":"Checkpoint inhibitors have the widest indication range of any oncology class, low marginal manufacturing cost and a demonstrated survival benefit in cancers common in LMICs; without a demand signal, manufacturers will serve the highest-margin markets first.","test":"Structure the commitment with two or three anchor funders, announce it three years before patent expiry, and track prequalification filings, supply volumes and prices against the trastuzumab biosimilar precedent.","maturity":"speculative","actor":"philanthropy","cost":"large","horizonYears":4},"route":"/ideas/idea-reg-pd1-biosimilar-advance-commitment/","neighbours":{"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"target":[{"id":"pd1","kind":"target","name":"PD-1","route":"/targets/pd1/"}],"drug":[{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"}],"bottleneck":[{"id":"b-global-access","kind":"bottleneck","name":"Most of the world has almost no cancer care","route":"/bottlenecks/b-global-access/"},{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"}],"paper":[{"id":"paper-prasad-nat-rev-clin-oncol","kind":"paper","name":"The high price of anticancer drugs: origins, implications, barriers, solutions","route":"/key-papers/paper-prasad-nat-rev-clin-oncol/"}],"roadmap":[{"id":"global-access-roadmap","kind":"roadmap","name":"Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation","route":"/roadmaps/global-access-roadmap/"}]}}