Remicade, Enbrel, and Humira can help relieve rheumatoid arthritis, psoriasis, and inflammatory bowel disease, but these biologic drugs can easily cost thousands of dollars a month out of pocket. Less-expensive versions of these, known as biosimilars, could be an option, and three could be headed to the market soon: A Remicade biosimilar was approved in April, and a Food and Drug Administration advisory committee recommended approving biosimilars of both Enbrel and Humira in July.

But some patient and physician groups have questioned whether biosimilars are as safe and effective as their brand-name counterparts. That’s because biologics contain proteins and often other compounds that can’t be replicated exactly, which means that a biosimilar is a close match but not identical to a biologic.

A new analysis published August 2 by the Annals of Internal Medicine should help put some of those concerns to rest.

The study, by researchers at Johns Hopkins Bloomberg School of Public Health in Baltimore and Brigham and Women’s Hospital in Boston, found that biosimilars have the same safety and effectiveness as their corresponding brand-name biologic. That’s important for you, because biosimilars are expected to cost up to 40 percent less than brand-name counterparts, a savings projected to amount to billions of dollars over the next several years, according to separate analyses by the RAND Corporation and Express Scripts.

To find out how biosimilars stacked up to the brand-name drugs, the new study looked at 19 clinical trials and other studies that were used to get biosimilar versions of Remicade, Enbrel, and Humira approved in the U.S., Europe, and other countries. Almost all of the participants in the studies, which looked at adverse effects, effectiveness, and how the medications are absorbed and metabolized in the body, were healthy volunteers or people with rheumatoid arthritis.

“Our results suggest that, for this important class of drugs, the biosimilar versions appear to have the same safety and efficacy profiles as their branded counterparts,” says Caleb Alexander, M.D., an author of the study and a co-director of the Center for Drug Safety and Effectiveness​ at the Johns Hopkins Bloomberg School of Public Health.  

“This is great news for patients, because these products will force prices down on this common and costly used class of biologic therapies, and ultimately save patients, insurers, and the health system billions of dollars,” Alexander adds.

It could be a while before biosimilars become available. That's because the manufacturers of the original, brand-name biologics are challenging the biosmiliar manufacturers' patents in court, delaying the launch of the less-expensive biosimilars.

That's what's happening with the biosimilar, Inflectra, the generic version of Remicade. It was approved in the U.S. in April, but its launch is delayed due to an ongoing patent challenge.

The FDA hasn’t yet approved the biosimilars of Enbrel and Humira, but both are already embroiled in patent challenges by the brand manufacturers.  



Editor's Note: These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).