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Regulatory challenges with biosimilars: an update from 20 countries
Hye-Na Kang1, Robin Thorpe2, Ivana Knezevic1
1Department of Health Product Policy and Standards, World Health Organization, Geneva, Switzerland.
Annals of the New York Academy of Sciences
|November 22, 2020
Summary
The World Health Organization (WHO) identified challenges in biosimilar regulation, including product availability and quality. Solutions involve information exchange, reliance pathways, reassessment of older products, and robust pharmacovigilance for biosimilar safety and interchangeability.
Area of Science:
- Pharmaceutical Sciences
- Regulatory Science
- Public Health
Background:
- The World Health Organization (WHO) developed guidelines for biosimilar evaluation in 2009.
- Member states have faced challenges implementing these guidelines into regulatory practices.
- A 2019-2020 WHO survey highlighted persistent issues in biosimilar regulation.
Purpose of the Study:
- To identify remaining challenges in the regulatory evaluation of biosimilars.
- To propose opportunities and solutions for regulatory authorities to address these challenges.
- To enhance the global implementation of effective biosimilar regulatory frameworks.
Main Methods:
- Analysis of a 2019-2020 World Health Organization (WHO) survey on biosimilar regulatory practices.
- Identification of key challenges reported by member states.
- Synthesis of proposed solutions and opportunities for regulatory authorities.
Main Results:
- Four primary challenges were identified: unavailable reference products, resource limitations, variable product quality, and difficulties with interchangeability and naming.
- Proposed solutions include international information exchange, acceptance of foreign reference products, and reliance/joint review pathways.
- Recommendations also cover reassessment of pre-framework approved products and enhanced pharmacovigilance for safety and interchangeability.
Conclusions:
- Addressing challenges in biosimilar regulation requires international collaboration and adaptive regulatory strategies.
- Implementing proposed solutions can improve access to and confidence in biosimilar medicines.
- Robust regulatory oversight, including pharmacovigilance, is crucial for ensuring the safety and efficacy of biosimilars.
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