# An advance market commitment for PD-1 biosimilars for lower-income countries

Source: https://onco.cc/ideas/idea-reg-pd1-biosimilar-advance-commitment/  
OnCo record `idea-reg-pd1-biosimilar-advance-commitment` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- 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.
- Proposed 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

## Sources

- Bottleneck evidence (Prices and value): Prasad, De Jesús & Mailankody, The high price of anticancer drugs: origins, implications, barriers, solutions (Nat Rev Clin Oncol 2017): https://doi.org/10.1038/nrclinonc.2017.31

## Connected records

- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- targets: [PD-1](https://onco.cc/targets/pd1/)
- drugs: [Nivolumab](https://onco.cc/drugs/nivolumab/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- bottlenecks: [Most of the world has almost no cancer care](https://onco.cc/bottlenecks/b-global-access/), [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/)
- key papers: [The high price of anticancer drugs: origins, implications, barriers, solutions](https://onco.cc/key-papers/paper-prasad-nat-rev-clin-oncol/)
- roadmaps: [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/)

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