A 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.
HENRY KOTULA 