Response regarding Colombian regulation of biotherapeutic products / Respuesta sobre la regulación colombiana de los productos bioterapéutico
Rev Panam Salud Publica
; 41, sept. 2017
Artigo
em Inglês
| PAHO-IRIS
| 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:
Disponível
Coleções:
Bases de dados de organismos internacionais
Base de dados:
PAHO-IRIS
Assunto principal:
United States Food and Drug Administration
/
Saúde Pública
/
Colômbia
Aspecto:
Determinantes sociais da saúde
País/Região como assunto:
América do Sul
/
Colômbia
Idioma:
Inglês
Ano de publicação:
2017
Tipo de documento:
Artigo