Response regarding Colombian regulation of biotherapeutic products / Respuesta sobre la regulación colombiana de los productos bioterapéutico
Rev Panam Salud Publica
; 41, sept. 2017
Article
em En
| PAHOIRIS
| ID: phr-51092
Biblioteca responsável:
US1.1
ABSTRACT
[EXCERPT]. Regarding a letter by Erika Lietzan (1) addressing our article on regulating biotechnology drugs in Colombia (2), we offer the following response. As Lietzan states, it is true that there is a global consensus on the two regulatory pathways to obtaining market authorization for biological medicines the full dossier pathway for pioneer products and an abbreviated pathway for competitors (biosimilars), called the “comparability pathway” in Colombia. The scientific principles of the abbreviated pathway are clearly stated in our article, referencing the WHO Guidelines on Evaluation of Similar Biotherapeutic Products (3), which underscores the importance of demonstrating a high similarity of physicochemical and functional characteristics between the biocompetitor and the reference product...
Texto completo:
1
Coleções:
04-international_org
Base de dados:
PAHOIRIS
Assunto principal:
United States Food and Drug Administration
/
Saúde Pública
/
Colômbia
Aspecto:
Determinantes_sociais_saude
País/Região como assunto:
America do sul
/
Colombia
Idioma:
En
Ano de publicação:
2017
Tipo de documento:
Article