Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: Innovators, biosimilars, and intended copies

被引:39
作者
Castaneda-Hernandez, Gilberto [1 ]
Szekanecz, Zoltan [2 ]
Mysler, Eduardo [3 ]
Azevedo, Valderilio F. [4 ]
Guzman, Renato [5 ]
Gutierrez, Miguel [6 ]
Rodriguez, Wilfredo [7 ]
Karateev, Dmitry [8 ]
机构
[1] Inst Politecn Nacl, Ctr Invest & Estudios Avanzados, Dept Farmacol, Mexico City 07360, DF, Mexico
[2] Univ Debrecen, Med & Hlth Sci Ctr, Dept Rheumatol, H-4012 Debrecen, Hungary
[3] Org Med Invest, Buenos Aires, DF, Argentina
[4] Univ Fed Parana, Dept Med, BR-80060000 Curitiba, Parana, Brazil
[5] IDEARG, Bogota, Colombia
[6] Pontificia Univ Catolica Chile, Dept Clin Immunol & Rheumatol, Santiago, Chile
[7] Hosp Univ Caracas, Caracas, Venezuela
[8] Russian Acad Med Sci, Res Inst Rheumatol, Dept Early Arthrit, Moscow, Russia
关键词
Rheumatic diseases; Rheumatoid arthritis; Biopharmaceuticals; Tumor necrosis factor (TNF) antagonists; Biosimilars; Innovators; FOLLOW-ON BIOLOGICS; ANKYLOSING-SPONDYLITIS; PARALLEL-GROUP; DOUBLE-BLIND; INFLIXIMAB; CHALLENGE; THERAPIES; ARTHRITIS; PHARMACOKINETICS; IMMUNOGENICITY;
D O I
10.1016/j.jbspin.2014.03.019
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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. (C) 2014 Societe francaise de rhumatologie. Published by Elsevier Masson SAS. All rights reserved.
引用
收藏
页码:471 / 477
页数:7
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