Birmingham, AL—The American College of Rheumatology (ACR) is encouraging clinicians to incorporate, where appropriate, the use of biosimilar products into treatment plans of patients with rheumatic diseases.

In a new white paper, “The Science Behind Biosimilars - Entering a New Era of Biologic Therapy,” the specialty organization offers an overview of the scientific, clinical, economic, and prescribing issues related to biosimilar use. Among those are efficacy, competition, and drug pricing. 

That wasn’t always the ACR’s view. Like many physician groups, it counseled caution as biosimilars were being developed, evaluated, and approved. “Now that biosimilars have been used successfully in Europe, with rigorously acquired data supporting their broader use, and as the U.S. is on the verge of a similar transition, the ACR is poised to reconsider its position,” write the white paper’s authors.

“The ACR has closely followed the development, evaluation, and approval processes for biosimilar agents, in addition to observing their successful use in other countries,” explained lead author S. Louis Bridges, Jr., MD, PhD, of the University of Alabama at Birmingham, who chairs the ACR’s Committee on Research. “We are now confident that providers can recommend biosimilars as a safe, effective, and affordable option to patients, where appropriate.”

Background information in the article points out that the FDA has approved nine biosimilar medications, six of which are for treatment of rheumatic diseases, since the Biologics Price Competition and Innovation Act (BPCI Act) of 2009 was passed in an effort to reduce costs and increase patient’s access to the products.

According to the ACR overview, the only advantage of a biosimilar versus its reference product is likely to be lower cost, because the drugs should be therapeutically equivalent. The authors also note that biosimilars could boost competition among drug manufacturers and possibly keep drug costs down, but concede that whether that actually will occur remains unknown. 

The white paper also points to possible obstacles for the use of biosimilars, including drug copayments that are nearly as expensive as copayments for the reference drug, and that the lower-price drugs are negative for pharmacy-benefit manager business models.

“There are a variety of market-based and legislative factors that contribute to the accessibility of biosimilars,” emphasized coauthor Angus Worthing, MD, of the Georgetown University Medical Center who chairs the ACR’s Government Affairs Committee. “While we have yet to see broad cost-saving benefits in the U.S. marketplace, efforts from health care advocates, legislative measures, and the introduction of additional biosimilar options could help relieve the financial burden of patients using these therapies.”

Another possible issue is patient acceptance. The authors urge communication among providers, pharmacists, and patients to alleviate anxiety and reduce skepticism about the use of newly available medications, writing, “We remain optimistic that the use of biosimilars will improve patient access to biologic agents, allowing continued delivery of high quality healthcare to be realized at a lower cost to the individual patient.”

A related commentary by Roy Fleischmann, MD, of the University of Texas Southwestern Medical Center and Metroplex Clinical Research Center in Dallas raised some negative issues associated with biosimilars. “It is not at all clear that a biosimilar will be cheaper to the patient—it may be cheaper to the pharmacy benefit management firm, but this may not really help patient to access these medications,” Fleishmann argues. “It is also not clear that non-medical substitution will be effective in every patient nor has it been demonstrated that extrapolation is effective. These are the major questions remaining unanswered with respect to the use of biosimilars in rheumatic disease.”
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