Biosimilar TNF-α Inhibitors Comparable to Their Branded Biologics

Biosimilar tumor necrosis factor-alpha (TNF-α) inhibitors have very similar safety and effectiveness as their reference biologics, according to a systematic review and meta-analysis in the Annals of Internal Medicine.

“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,” study leader G Caleb Alexander, MD, an associate professor at Johns Hopkins University and co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, said in a press release. 

“Hopefully this will encourage the brisk adoption of these products,” he added. “There is no question that greater competition in this market will benefit patients, prescribers, and society in the long run.”

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Dr Alexander and colleagues at Johns Hopkins University came to their findings after analyzing 19 studies conducted through April 2016 that compared originator and biosimilar TNF-α inhibitors, a class of drugs used to treat patients with rheumatoid arthritis, inflammatory bowel disease, and psoriasis. Despite the paucity of studies, the researchers concluded that evidence supports both the biosimilarity and the interchangeability of TNF-α inhibitors, especially for patients with rheumatoid arthritis. 

Only 1 TNF- α inhibitor biosimilar has received FDA approval to date. A biosimilar of the biologic Remicade (infliximab; Janssen Biotech), Inflectra  (infliximab-dyyb; Celltrion) was approved in April. 

Some have argued that because biologics use living cells and are complicated to manufacture, biosimilars should not be considered interchangeable with biologics that have been on the market for years.

“The billion-dollar question has been whether these ‘generic biologics’ are the same as the brand-name versions,” Dr Alexander said. “The same debate occurred with the advent of less complicated generic drugs and now it is 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… the products we studied appear comparable, and they will definitely be cheaper,” he concluded.—Jolynn Tumolo