Inflammatory Biosimilar Comparable to Branded Biologic

A new analysis revealed that the generic forms of a biologic drug to treat inflammation in patients with rheumatoid arthritis (RA) and inflammatory bowel syndrome (IBS) are comparable in safety and efficacy to their branded counterparts.

Biologics are made from living cells, and are the fastest growing sector of the pharmaceutical market. Companies have argued that their generic forms, biosimilars, cannot be considered interchangeable with already established drugs that have been on the market for years.

In a study published in the Annals of Internal Medicine, researchers determined that the tumor necrosis factor-alpha (TNF-α) inhibitor drug class were comparable to their biologics.

“The billion-dollar question has been whether these generic biologics are the same as the brand-name versions,” said study leader Caleb G. Alexander, MD. “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.”

For the study, researchers analyzed the scientific literature to compare original and biosimilar forms of TNF-α inhibitors for RA, inflammatory bowel disease (IBD), and psoriasis. Data was collected from 19 studies conducted through April 2016. The results of the study suggest that biosimilars have similar safety and efficacy as their brand name counterparts, despite the limited amount of available studies.

As of April, the FDA approved the first and only TNF-α inhibitor biosimilar Inflectra, which is biosimilar for infliximab (Remicade). Other branded TNF-α inhibitors in the marketplace include Cimzia, Enbrel, Humira, and Simponi.

“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,” 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.”

Although the study only applies to TNF-α inhibitors, authors noted that it is an important and rigorous first look at a question on the minds of people worried about the future of a generic-type market for biologic drugs.

“Biologics are the wave of the future,” Alexander said. “That’s where more and more of the pharmaceutical market is going in the years ahead.”

The analysis was conducted by researchers at the Johns Hopkins Bloomberg School of Public Health and supported by the Johns Hopkins Center of Excellence in Regulatory Science and Innovation.