- Todos > Medicine Information and Evidence for Policy > Information and Publications
- Todos > Quality and Safety: Medicines > Regulatory Support
- Todos > WHO Prequalification of Medical Products > WHO-UNICEF-UN Project
- Palabras clave > bioequivalent generic products
- Palabras clave > equivalence assessment - interchangeable multisource (generic) products
- Palabras clave > generic medicines
- Palabras clave > interchangeability - registration requirements
- Palabras clave > interchangeable multisource (generic) products
- Palabras clave > medicines regulatory authority (MRA)
- Palabras clave > Multisource (Generic) Pharmaceutical Product
- Palabras clave > Prequalification of Medicines Programme - WHO
- Palabras clave > quality of generics
- Palabras clave > regulatory harmonization
(2016; 6 pages)
Generic medicines can enable huge cost-savings as they create competition, driving down prices. In medicines regulation and in WHO prequalification, the efficacy of generics is demonstrated by bioequivalence studies.
WHO medicines prequalification has facilitated academic research, and has itself been a subject of academic research. Adjusted indirect comparisons were conducted, using the results of separate bioequivalence studies for WHO-prequalified generics against the same comparator product. The comparisons found that the generics can be considered as clinically equivalent among each other. Recommendations are provided for regulatory assessment of generics in WHO Member States and for possible approaches to harmonization of bioequivalence requirements to facilitate access to needed products.