new study suggests that a group of biosimilar drugs, which are used to treat such afflictions as rheumatoid arthritis, psoriasis, and inflammatory bowel disease, appear as safe and effective as their more expensive brand-name counterparts, which are known as biologics. A biosimilar drug is a nearly identical variant of a biologic and is expected to provide the same result in patients.

The analysis arrives as the US health care system, which is increasingly overwhelmed by high-priced medicines, looks toward biosimilars to provide savings. In the United States, where regulators have approved just two such drugs, some estimates say prices will be 20 percent to 30 percent less than the cost of biologics.

But until more biosimilars become available, there is some debate over the extent to which physicians will become sufficiently comfortable prescribing these drugs. Biologics are made from living cells and the brand-name biotech industry, for instance, says the complex processes needed to develop biosimilar drugs may produce slight changes that can affect safety and effectiveness. The threat of lower-priced competition has prompted brand-name drug makers to petition the Food and Drug Administration to delay approvals, among other tactics.


The study authors, however, argue their findings should put some of those concerns to rest. After analyzing 19 studies, they maintain the available data indicates biosimilar drugs based on brand-name versions of anti-TNF inhibitors should be considered interchangeable. The anti-TNF inhibitors include such big sellers as Amgen’s Enbrel, AbbVie’s Humira, and Johnson & Johnson’s Remicade.

“This is the $1 billion question — are the biosimilar versions comparable? And we found, in just about every outcome examined, that the biosimilars fare very well,” said Dr. Caleb Alexander, who is codirector of the Johns Hopkins University Center for Drug Safety and Effectiveness, and one of the authors of the study, which appeared today in the Annals of Internal Medicine.

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”You’ll hear arguments there is not only variation in biosimilars from manufacturer to manufacturer, but also from batch to batch,” he continued. “And this is used as a means to discourage policies that would promote adoption of biosimilars. Our study suggests this is not true and should give physicians and payers additional confidence.”

A great deal is at stake. Biologics are an increasingly large chunk of the prescription-drug market. Spending on these medicines almost doubled over the past five years, to $129 million last year, and accounted for 54 percent of the growth in prescription drug spending since 2010, according to the IMS Institute for Health Informatics, a market research firm.

Looking ahead, there are eight big-selling biologic drugs in the US with expiring patents and looming development by biosimilar rivals. Taken together, their sales are expected to exceed $200 billion by 2020, according to IMS. And this batch includes Humira and Remicade, which are also used to treat inflammatory bowel disease, as well as Enbrel.

These are all huge sellers. Last year, for instance, Enbrel generated $5 billion for Amgen, while Johnson & Johnson rang up $6.5 billion in Remicade sales, and Humira generated $8.4 billion in the US for AbbVie. Whether biosimilars yield substantial savings, however,  remains to be seen. Some brand-name drug makers have been raising prices for their biologics in anticipation of the competition, prompting biosimilar makers to raise their own prices.

“I think the study makes an important contribution to understanding the issues of surrounding bioequivalence, specifically regarding anti-TNF inhibitors,” said Murray Aitken, who heads the IMS Institute. “It suggests that the biosimilarity and interchangeability of these drugs look positive, in terms of limited side effects or other complications.”

We asked the Biotechnology Innovation Organization, the industry trade group, for comment and will update you accordingly.

There is at least one caveat, however. In the FDA’s view, a biosimilar drug is highly similar to a biologic and has no clinically meaningful difference in terms of safety and effectiveness. An interchangeable biologic medicine must meet additional standards, and the agency may require additional clinical trial data to reach this threshold.

Alexander also noted that “this is just one class of medicines. We have to be cautious about inferring that other classes of biosimilars are similarly safe and effective based on this analysis. It may be they do just as well upon examination, but we didn’t examine those. So our analysis shouldn’t be used to infer too much about [the] broader world of biologics.”

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