Objective:
To improve access to medicines in middle- and low-income countries through effective regulatory oversight and the prequalification of biosimilars.
Approach:
- WHO Prequalification Program: A team of assessors evaluates data from medicine makers, and inspectors verify compliance with WHO good manufacturing practices.
- Pilot Project for Biosimilars: The WHO has launched a pilot project for prequalifying biosimilar medicines, starting with rituximab and trastuzumab.
Key Findings:
- WHO prequalification traditionally focused on diseases like HIV, malaria, and TB.
- The new pilot project allows applications for biosimilars to be submitted in September.
- Insulin prequalification is also being explored.
Interpretation:
Conclusion:
The WHO aims to update its guidelines to reflect recent evidence and experience in the evaluation of similar biotherapeutic products.
Sources:
This content is an AI-generated, fully rewritten summary based on a published scholarly article. It does not reproduce the original text and is not a substitute for the original publication. Readers are encouraged to consult the source for full context, data, and methodology.
