Generic biologic drug comparable to brand name version, study says

Researchers reviewed data on the safety and efficacy of the first biosimilar to be approved by the FDA, Inflectra.
By Stephen Feller   |   Aug. 2, 2016 at 10:31 AM

BALTIMORE, Aug. 2 (UPI) -- Generic versions of drugs make medication available to more people at a lower price, but concerns about the ability to create generic biologic drugs close enough to the brand name originators has slowed their creation.

Researchers at Johns Hopkins University report the generic form of infliximab, or Remicade, is as safe and effective as the original, suggesting the concerns may be overblown.

Biologics are made from living cells, requiring specific manufacturing practices that, even when precisely followed, can result in varying batches. Since small changes in production can alter the medications, it is impossible to create a precise replica.

The U.S. Food and Drug Administration approved the first generic form of a biologic drug, or biosimilar, in April.

Inflectra, a biosimilar for Remicade, is a tumor necrosis factor-alpha, or TNF-α, inhibitor meant to prevent inflammation as part of treatment for arthritis, IBS and other chronic conditions.

Researchers at Johns Hopkins say the drug has been shown to be as safe and effective as the original, based on their recent study, and expect to see more like it because of myriad benefits it could bring, from enhanced competition in the drug market to lower costs for patients.

"Our study should reassure clinicians and patients and, importantly, the folks who pay the bills -- insurance companies and government programs like Medicare ­-- that biosimilar TNF-α inhibitors appear comparable to their branded counterparts based on the evidence we have thus far," Dr. Caleb Alexander, an associate professor at Johns Hopkins and director of the university's Center for Drug Safety and Effectiveness, said in a press release.

For the study, published in the journal Annals of Internal Medicine, researchers analyzed 19 studies on Inflectra, finding the drug trials showed the original biologic and the biosimilar were similar in safety and efficacy.

The researchers report adverse health events were generally mild to moderate in severity, with four of the studies showing patients who switched from the original drug to the biosimilar found the same efficacy and safety.

"The billion-dollar question has been whether these 'generic biologics' are the same as the brand-name versions," Alexander said. "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."

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