# WHO prequalification plus pooled demand to push biosimilar prices below 10% of the originator

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

## TL;DR

Biosimilars of trastuzumab, rituximab and bevacizumab have existed for years, but poorer countries cannot assess biologics themselves and place small fragmented orders. Extending WHO prequalification, begun with trastuzumab in 2019, to every oncology biosimilar and pooling procurement would give buyers assurance and makers volume, aiming below a tenth of originator prices.

## Summary

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.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Prequalified biosimilars purchased through a pooled mechanism will be available in at least 20 additional low-income countries within three years at prices below 10% of the originator's high-income list price.
- Rationale: Prequalification did this for HIV antiretrovirals and vaccines; biologics are more complex to assess, but the assessment is done once and used by many.
- Proposed test: Track prequalification throughput, participating country count, price per vial, and share of eligible patients receiving trastuzumab for HER2-positive breast cancer in participating versus non-participating countries.
- Maturity: early-clinical
- Actor: regulator

## Sources

- Bottleneck evidence (Most of the world has almost no cancer care): WHO fact sheet, Cancer: https://www.who.int/news-room/fact-sheets/detail/cancer

## Connected records

- cancers: [Diffuse large B-cell lymphoma](https://onco.cc/cancers/dlbcl/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- technologies: [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- drugs: [Trastuzumab](https://onco.cc/drugs/trastuzumab/)
- 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/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)
- 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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