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001-es BibID:BIBFORM056668
Első szerző:Castaneda-Hernández, Gilberto
Cím:Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India : innovators, biosimilars, and intended copies / Gilberto Castaneda-Hernández, Zoltan Szekanecz, Eduardo Mysler, Valderilio F. Azevedo, Renato Guzmane, Miguel Gutierrez, Wilfredo Rodríguez, Dmitry Karateev
ISSN:1297-319X 1778-7254
Megjegyzések: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 beenapproved for rheumatoid arthritis. However, incountries 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.
Tárgyszavak:Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Rheumatic diseases
Rheumatoid arthritis
Tumor necrosis factor (TNF) antagonists
Megjelenés:Joint Bone Spine 81 : 6 (2014), p. 471-477. -
További szerzők:Szekanecz Zoltán (1964-) (reumatológus, belgyógyász, immunológus) Mysler, Eduardo Azevedo, Valderilio F. Guzmane, Renato Gutierrez, Miguel Rodríguez, Wilfredo Karateev, Dmitry
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