title: Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: innovators, biosimilars, and intended copies.
abstract: A biosimilar is a biopharmaceutical product intended to be comparable to a previously licensed biopharmaceutical agent. The goal of such products is to increase the accessibility of biopharmaceutical therapy for rheumatoid arthritis by reducing costs. They are not like generic drugs, in that they may differ from the reference products in manufacturing, composition, and formulation. Regulatory authorities strive to ensure the absence of clinically meaningful differences between biosimilars and their reference drugs. However, small molecular differences may potentially affect pharmacodynamics (including affinity), pharmacokinetics, and immunogenicity. Intended copies are non-innovator biopharmaceutical products that, unlike biosimilars, do not have enough clinical evidence to demonstrate biosimilarity. For approval of a biosimilar, most countries require preclinical and clinical studies demonstrating comparability with the reference drug. The margin for determining equivalence or non-inferiority is determined on a case-by-case basis in each country, as there are no general criteria. The European Medicines Agency and US Food and Drug Administration have stringent regulatory processes to ensure comparability of biosimilars with their reference drugs. There are also post-marketing surveillance requirements to monitor safety. Only one biosimilar, CT-P13, has been approved for rheumatoid arthritis. However, in countries with less stringent regulation, intended copies are being commercialized and safety problems have been documented. Consequently, in such countries, there is an urgent need for appropriate regulatory processes to be established. Attempts to close the affordability gap of biopharmaceuticals should not open another gap between patients treated with an innovator drug and an intended copy.
authors: Departamento de Farmacología, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional, Mexico City, Mexico. Electronic address: gcastane@cinvestav.mx.
authors: Gilberto
authors: G
authors: Castañeda-Hernández
authors: Department of Rheumatology, University of Debrecen Medical and Health Sciences Center, Debrecen, Hungary.
authors: Zoltan
authors: Z
authors: Szekanecz
authors: Organización Médica de Investigación, Buenos Aires, Argentina.
authors: Eduardo
authors: E
authors: Mysler
authors: Department of Medicine, Universidade Federal do Paraná, Curitiba, Brazil.
authors: Valderilio F
authors: VF
authors: Azevedo
authors: Chief of ImmunoRheumatology Saludcoop Clinic and Scientific Director of IDEARG, Bogota, Colombia.
authors: Renato
authors: R
authors: Guzman
authors: Department of Clinical Immunology and Rheumatology, Pontificia Universidad Católica de Chile, Santiago, Chile.
authors: Miguel
authors: M
authors: Gutierrez
authors: Hospital Universitario de Caracas, Caracas, Venezuela.
authors: Wilfredo
authors: W
authors: Rodríguez
authors: Department of Early Arthritis, Research Institute of Rheumatology of Russian Academy of Medical Sciences, Moscow, Russia.
authors: Dmitry
authors: D
authors: Karateev
mesh_terms: D001702:Biopharmaceutics; D059451:Biosimilar Pharmaceuticals; D016568:Drugs, Generic; D005060:Europe; D006801:Humans; D007194:India; D007843:Latin America; D012216:Rheumatic Diseases / Q000188:drug therapy*; D012426:Russia
chemical_list: D059451:Biosimilar Pharmaceuticals; D016568:Drugs, Generic
keywords: Biopharmaceuticals; Biosimilars; Innovators; Rheumatic diseases; Rheumatoid arthritis; Tumor necrosis factor (TNF) antagonists