WHO prequalification plus pooled demand to push biosimilar prices below 10% of the originator
Cheap copies of key antibody drugs exist but many countries cannot check their quality. A WHO quality stamp plus large pooled orders would make them safe to buy and very cheap.
Biosimilars of trastuzumab, rituximab, and bevacizumab have been on the market for years, but uptake in LMICs is limited by regulatory capacity to assess biologics, fear of poor-quality products, and small, fragmented orders. WHO prequalification of biosimilars began with trastuzumab in 2019. Extending prequalification to the full oncology biosimilar set and coupling it with pooled procurement (through PAHO's Strategic Fund, UNICEF, or a new mechanism) would give buyers assurance and manufacturers volume.
- 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.
- 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.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
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