Response regarding Colombian regulation of biotherapeutic products
MetadataShow full item record
[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...
Respuesta sobre la regulación colombiana de los productos bioterapéutico
Category of PAHO Strategic Plan 2014-2019
Vaca González C, Gómez C y Gaviría A. Respuesta sobre la regulación colombiana de los productos bioterapéuticos. Rev Panam Salud Publica. 2017;41:e135.
This notice should be preserved along with the article's original URL.Attribution-NonCommercial-NoDerivs 3.0 IGO
Showing items related by title, author, creator and subject.
Lietzan, Erika (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 ...
Batista, Carolina; Forsyth, Colin J.; Herazo, Rafael; Certo, Marina Pereira; Marchiol, Andrea (2019)[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 ...
Multidrug-resistant Salmonella spp. in fecal samples of pigs with suspected salmonellosis in Antioquia, Colombia, 2019–2021 Vidal, Juana L.; Clavijo, Viviana; Castellanos, Luis R.; Kathiresan, Jeyashree; Kumar, Ajay M.V.; Mehta, Kedar; Chaparro-Gutiérrez, Jenny J. (2023-04-19)[ABSTRACT]. Objectives. To determine the proportion of Salmonella enterica in fecal samples of live pigs with suspected salmonellosis analyzed at the diagnostic unit of the University of Antioquia, Colombia between 2019 ...