Αρχειοθήκη ιστολογίου

Τρίτη 15 Αυγούστου 2017

How similar are the treatment responses to biosimilars in patients with psoriasis? A systematic review of statistical margins in comparative clinical trials

To the Editor: Biosimilars are medications that have no clinically meaningful differences in terms of safety, purity, and potency relative to a reference drug product that has already obtained approval from the Food and Drug Administration.1 These drugs are often investigated by equivalence trials wherein the biosimilar is determined clinically to be neither inferior nor superior when compared with its originator. Because of the complex molecular nature of biosimilars, manufacturing identical replicas of corresponding originators is impossible.

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