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Generic Drug Study: Biosimilars OK for Arthritis, IBD, Psoriasis

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By    |   Wednesday, 03 Aug 2016 12:58 PM

Generic biologic drugs are just as safe and effective as their brand-name counterparts at treating rheumatoid arthritis, inflammatory bowel disease, and psoriasis, a new study suggests.

The study by the Johns Hopkins Bloomberg School of Public Health examined multiple biologics, made from living cells, which are complicated to manufacture. The class of drugs represents a growing sector expected to reach 20 percent of the pharmaceutical market by 2017, according to a news release.

The study was published Tuesday in the Annals of Internal Medicine.

"The billion-dollar question has been whether these ‘generic biologics’ are the same as the brand-name versions," said study leader G. Caleb Alexander, MD, an associate professor in the Department of Epidemiology at the Bloomberg School and co-director of the Johns Hopkins Center for Drug Safety and Effectiveness. "The same debate occurred with the advent of less complicated generic drugs and now it’s being hashed out all over again with much more at stake – more room for error and more potential for cost savings to the health system. But based on the available evidence, we conclude that the products we studied appear comparable, and they will definitely be cheaper."

The researchers examined 19 studies conducted through April 2016 to reach their conclusion.

Biologics are susceptible to small changes in manufacturing processes that can alter their structure. Variations can occur between different batches made in the same facility, raising questions about the viability of generic versions, known as biosimilars.

The study comes at a time when the patents of many brand-name biologics are set to expire, HealthDay noted via WebMD. Cheaper biosimilars could save the health care industry significantly and have uses in the treatment of everything from diabetes to cancer.

The study focused on Inflectra, the first biosimilar approved by the Food and Drug Administration. Alexander said further research into other types of biosimilars is necessary, the International Business Times reported.

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Generic biologic drugs are just as safe and effective as their brand-name counterparts at treating rheumatoid arthritis, inflammatory bowel disease, and psoriasis, a new study suggests.
generic, drug, study, biosimilar, arthritis, ibd, psoriasis
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2016-58-03
Wednesday, 03 Aug 2016 12:58 PM
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