Biosimilar Biologics Appear As Safe, Effective As Reference Rx

Share this content:
Biosimilar Biologics Appear As Safe, Effective As Reference Rx
Biosimilar Biologics Appear As Safe, Effective As Reference Rx

TUESDAY, Aug. 2, 2016 (HealthDay News) -- Biosimilar biologic drugs are appropriately interchangeable with reference biologics in treating rheumatoid arthritis, inflammatory bowel disease, and psoriasis, 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-alpha 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.

Full Text (subscription or payment may be required)
Editorial (subscription or payment may be required)

Share this content:

is free, fast, and customized just for you!

Already a member?

Sign In Now »


Sign up for myCME e-newsletters


Drug Lookup

Browse drugs by: BrandGenericDisease


More in Home

Hormonal Contraception May Raise Depression Risk

Hormonal Contraception May Raise Depression Risk

Study also ties hormonal patches, IUDs to greater antidepressant use, especially in teens

Dose-Dependent Link Between Cannabis Use, Psychosis Relapse

Dose-Dependent Link Between Cannabis Use, Psychosis Relapse

But researchers note effect is small, and the research isn't definitive

Systolic Blood Pressure Variability Linked to Mortality, Morbidity

Systolic Blood Pressure Variability Linked to Mortality, Morbidity

Increased SBP variability tied to mortality, coronary heart disease, stroke, end-stage renal disease

is free, fast, and customized just for you!

Already a member?

Sign In Now »