Pharmacokinetic parameters of both versions within the prespecified equivalence margin
TUESDAY, Aug. 2, 2016 (HealthDay News) — Biosimilar and reference tumor necrosis factor-α inhibitors appear to be appropriately interchangeable, according to a review published online Aug. 2 in the Annals of Internal Medicine.
G. Caleb Alexander, M.D., of the Bloomberg School of Public Health and Johns Hopkins Center for Drug Safety and Effectiveness in Baltimore, and colleagues reviewed 19 studies. The studies were conducted through April 2016. The researchers looked at the use of biosimilar and reference tumor necrosis factor-α inhibitors to treat rheumatoid arthritis, inflammatory bowel disease, and psoriasis.
The team found that all phase 1 trials showed pharmacokinetic parameters of the biosimilar and respective biologic to be within the prespecified equivalence margin of 80 to 125 percent. Similar clinical responses and adverse effects, usually of mild to moderate severity, were seen in phase 3 trials. Two cross-sectional observational studies demonstrated cross-reactivity between products. Similar efficacy and safety was suggested in four cohort studies of patients switched from reference to biosimilar products.
“Based on the available evidence, we conclude that the products we studied appear comparable, and they will definitely be cheaper,” Alexander said in a university news release.
Several authors disclosed financial ties to the pharmaceutical industry.
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