title: The Regulation of Biosimilars in Latin America.
abstract: This article summarizes the regulatory scenario on biological medications in Latin America focusing on comparability studies, extrapolation of indications, interchangeability and pharmacovigilance issues. In the case of comparability studies, what is being discussed is the possibility of decreasing the clinical trials requirement, but that the molecule should be well characterized in the studies of pharmacokinetics and pharmacodynamics. With the worldwide-level approval of the first monoclonal antibody biosimilar, infliximab, extrapolation of indications are being discussed, since the behavior of the Latin America regulatory agencies has been different with regard to such issue. Another issue discussed by the regulatory agencies is the interchangeability between biological medications and their biosimilars, mainly due to the fact that there is a clear confusion on interchangeability and substitution concepts. Finally, the pharmacovigilance debate, according to what takes place globally, is related to the need for identifying and differentiating the reference biological medication and its biosimilars for traceability purposes.
authors.affiliation: Latin American Center for Biological Research (CLAPBio), Rua São José, 696, Alto da Boa Vista, São Paulo, SP, Brazil, ZIP 04739-001. ricardogarcia@clapbio.com.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Garcia
authors.affiliation: Internal Medicine Department at State University of Rio de Janeiro, Boulevard 28 de setembro 77, room 329, Vila Isabel, Rio de Janeiro, Brazil, ZIP 20551-030. denizar@uerj.br.
authors.forename: Denizar Vianna
authors.initials: DV
authors.lastname: Araujo
mesh_terms: D059451:Biosimilar Pharmaceuticals / Q000592:standards*; D057915:Drug Substitution / Q000592:standards; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence / Q000379:methods*; D006801:Humans; D007843:Latin America; D060735:Pharmacovigilance; D013810:Therapeutic Equivalency
chemical_list: D059451:Biosimilar Pharmaceuticals
keywords: Biosimilars; Extrapolation of indications; Interchangeability; Latin America; Pharmacovigilance; Regulation