Published August 10, 2016
Biosimilars Appear to Be as Safe, Effective as Original Biologic Drugs
Baltimore—Even when manufactured by different companies, common and costly medications made from living cells can be equivalent, according to a new analysis.
The article published in Annals of Internal Medicine reports that generic forms of a biologic drug used to treat rheumatoid arthritis, inflammatory bowel disease, and psoriasis appear to be as safe and effective as their brand-name counterparts.
Background information in the article notes that biologics are the fastest growing sector of the pharmaceutical market but that the products are complicated to manufacture, leading to the argument that generic forms—while they would be less expensive—cannot be considered interchangeable with established drugs that have been on the market for years.
Due to the large, complex structures of biologics and the variability inherent in the manufacturing process, a precise replica, or “generic version,” of a biologic cannot be created, which is why they are called “biosimilars.” In fact, batch-to-batch variation sometimes occurs in products manufactured in the same facility by the same methods, according to background information in the study.
“The billion-dollar question has been whether these ‘generic biologics’ are the same as the brand-name versions,” explained 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.”
By 2017, sales for biologics are expected to represent approximately 20% of the total pharmaceutical market and, study authors point out, wide adoption of biosimilars could eventually save the U.S. healthcare system billions of dollars.
For the study, the research team compared original and biosimilar forms of tumor necrosis factor-alpha (TNF-alpha) inhibitors used to treat rheumatoid arthritis, inflammatory bowel disease and psoriasis. The drugs suppress the activity of TNF, which can cause inflammation and lead to immune-system diseases.
Using data from 19 studies conducted through April 2016, researchers determined that, despite a small number of studies, available data suggests that biosimilar drugs are as safe and effective as the branded versions.
“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-alpha inhibitors appear comparable to their branded counterparts based on the evidence we have thus far,” Alexander said. “Hopefully this will encourage the brisk adoption of these products. There is no question that greater competition in this market will benefit patients, prescribers and society in the long run.”
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