title: [The debate on regulating biotechnology drugs: Colombia in the international context].
abstract: In September 2014, Colombia issued standards for the evaluation of biological drugs within the framework of the marketing authorization process. The Colombian approach explicitly includes a fast track for evaluating competing biologicals, which caused great national and international controversy. This article explains the context that justifies the need for this fast-track approach, critically analyzes comparability as a paradigm for the evaluation of biogenerics, and shows that Colombia's position is not isolated and is based on global regulatory trends.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Gaviria
authors.forename: Claudia Patricia Vaca
authors.initials: CP
authors.lastname: González
authors.forename: Carolina Gómez
authors.initials: CG
authors.lastname: Muñoz
authors.forename: Álvaro Andrés
authors.initials: ÁA
authors.lastname: Morales
mesh_terms: D001688:Biological Products; D001709:Biotechnology / Q000331:legislation & jurisprudence / Q000592:standards; D003105:Colombia; D006801:Humans; D038622:Internationality; D007880:Legislation, Drug; D040541:Marketing
chemical_list: D001688:Biological Products