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Bioequivalence of biosimilar tumor necrosis factor-a inhibitors compared with their reference biologics

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Biosimilar versions of tumor necrosis factor-a (TNF-a) inhibitors may be a viable substitution for the biologic drugs they mimic, researchers have determined.

Biosimilar versions of tumor necrosis factor-a (TNF-a) inhibitors may be a viable substitution for the biologic drugs they mimic, researchers have determined. A systematic review analyzed eight phase I randomized trials involving mostly healthy volunteers, five phase III randomized trials populated by rheumatoid arthritis (RA) patients, and six observational studies including patients with RA or inflammatory bowel disease. The results indicated the biosimilars were pharmacokinetically comparable to the reference biologics—achieving equivalence within the targeted range of 80%–125%, with similar clinical and safety outcomes. While there is early evidence that biosimilars can be used in place of reference TNF-a inhibitors, the investigators acknowledge the small sample size of some studies, the absence of published results for several biosimilars, and the potential for publication bias.

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http://annals.org/article.aspx?articleid=2540851

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