OnCo
ideasIdea

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

Immunotherapy patents start expiring around 2028. Guaranteeing in advance to buy cheap copies for poorer countries would make sure manufacturers build the capacity.

Pembrolizumab and nivolumab lose key patent protection in major 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.

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.
What would test it
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
Who has to act
philanthropy
Cost to try
Large (over $50M)
Years to first evidence
4
Bottlenecks it attacks
  • Prices and value · New cancer drugs routinely cost over $150,000 a year, often for months of benefit. Systems cannot afford them and patients go bankrupt.
  • Most of the world has almost no cancer care · Seven in ten cancer deaths happen in low- and middle-income countries, where radiotherapy, pathology, surgery and drugs are scarce.

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