Response regarding Colombian regulation of biotherapeutic products
Resumo
[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...
Título traduzido
Respuesta sobre la regulación colombiana de los productos bioterapéutico
Categoria do Plano Estratégico 2014-2019 da OPAS
Cita
Vaca González C, Gómez C y Gaviría A. Respuesta sobre la regulación colombiana de los productos bioterapéuticos. Rev Panam Salud Publica. 2017;41:e135.
Collections
Este aviso deve ser preservado juntamente com o URL original do artigo.Attribution-NonCommercial-NoDerivs 3.0 IGO
Itens relacionados
Apresentado os itens relacionados pelo título, autor e assunto.
-
How Colombia’s biosimilar regulation departs from international norms
(2017-09)Dear editor I write in response to an article published in January 2016 regarding Colombia’s 2014 regulation governing registration of biosimilar biological products (1). In my view, the article seriously misstates ... -
A four-step process for building sustainable access to diagnosis and treatment of Chagas disease
(2019-09)[ABSTRACT]. The vast majority of people with Chagas disease (CD) are undiagnosed and untreated. Improving access to diagnosis and treatment for CD involves confronting a wide range of barriers. This report discusses a ... -
United States Food and Drug Administration’s authorization of reduced exposure claims for IQOS®: implications for regulation in Latin America
(2022-10-10)[ABSTRACT]. Philip Morris International has used the July 7, 2020 United States Food and Drug Administration’s (US FDA) modified risk tobacco product order for IQOS®, which authorized certain reduced exposure marketing ...
