The implementation of the bioequivalence certification policy in Chile: an analysis of market authorization data
PLoS One
; 14(5): 1-12, May 2019.
Artículo
en Inglés
| PIE
| ID: biblio-1021475
Biblioteca responsable:
BR1.1
ABSTRACT
Affordability is a key barrier to access to medicines. Generic medicines policies can address this barrier and promote access. Successful uptake of generic medicines depends, in part, on ensuring that these products are interchangeable with reference products. Typically, bioequivalence certification is established in order to demonstrate such interchangeability. To study the implementation of the bioequivalence certification policy in Chile. We used Chilean Market Regulatory Authority data for analysis to study the number of products that obtained bioequivalence certification, the time until bioequivalence certification and associated factors to obtain bioequivalence. As of January 2017, out of 2,336 products with a valid market authorization containing at least one of the 167 APIs that required BE certification, 1,026 products actually have BE certification (1,026/2,336, 43.9% compliance). Where data were available, the time between submission of the market authorization as a bioequivalent product to final authorization by the national medicine regulatory authority for most products varied between 4-6 months. The fraction of all BE products containing a given API out of the total marketed products containing that API varies considerably, e.g. for the API olmesartan there was only a single BE product marketed, the API diclofenac had none. Although the implementation of Chile's bioequivalence policy increased the number of bioequivalent products, over 50% of generic products requiring bioequivalence that did not obtain this certification. Also for some of the API none or very few BE products are marketed which limits the success of a substitution policy. Further studies are required to identify the apparent lack of incentives to obtain bioequivalence certification. Studies of sales volumes and prices of the products are needed to identify whether generic products without bioequivalence certification either become bioequivalent or eventually exit the market.
Texto completo:
Disponible
Colección:
Bases de datos internacionales
Contexto en salud:
Agenda de Salud Sostenible para las Américas
/
ODS3 - Salud y Bienestar
Problema de salud:
Objetivo 5: Medicamentos, vacunas y tecnologías sanitarias
/
Meta 3.8: Alcanzar cobertura universal de salud
Base de datos:
PIE
Asunto principal:
Medicamentos Genéricos
/
Política de Medicamentos Genéricos
/
Acceso a Medicamentos Esenciales y Tecnologías Sanitarias
Tipo de estudio:
Estudio pronóstico
Idioma:
Inglés
Revista:
PLoS One
Año:
2019
Tipo del documento:
Artículo
Institución/País de afiliación:
Boston University School of Public Health/US
/
Ministry of Health Chile/CL