Differing Views on Switching Biosimilars at ACR 2017
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SAN DIEGO — The 2017 ACR/ARHP Annual Meeting featured a debate that presented differing viewpoints from the rheumatology community of the benefits and consequences of switching to biosimilars.
Jonathan Kay, MD, professor of medicine at the University of Massachusetts Medical School in Worcester, Massachusetts, argued that it is safe, effective, and cost-effective to switch to a biosimilar. He noted that biosimilars undergo rigorous analytical and clinical assessment in comparison to the reference product and are approved by a regulatory agency according to a specific pathway for biosimilar evaluation.
Dr. Kay discussed the results of the NOR-SWITCH trial, which found that switching from infliximab treatment was noninferior to continued treatment with a biosimilar infliximab. The results demonstrated comparable long-term safety and efficacy after 52 weeks.
Dr. Kay stated that biosimilars will also increase access for patients who did not have access to the bio-originator. Greater global access to effective biopharmaceuticals should reduce disability, morbidity, and mortality associated with inflammatory diseases.
“The potential risk to the individual of switching to a lower-cost biosimilar should be outweighed by the potential benefit to society of expanding access to care for all,” Dr. Kay concluded.
In his opposing argument, Roy Fleischman, MD, MACR, clinical professor of medicine at University of Texas Southwestern Medical Center in Dallas, Texas, noted that one study cannot be generalized to all indications. It is not absolutely certain that an individual patient will maintain efficacy if they switch from a bio-originator disease-modifying antirheumatic drug (DMARD) to a biosimilar DMARD. “We don't know if switching amongst multiple biosimilar DMARDs in an individual patient will be safe or efficacious,” he noted.
Dr. Fleischman also stated that the only legitimate reason to use a biosimilar DMARD is defined by a reduction in cost and increased patient access. Biosimilars are generally priced lower than their reference products. However, with the rebate system in the United States, where a pharmaceutical benefit manager or vertical health care system obtain rebates from pharmaceutical manufacturers so that their medication is preferred, patients are charged full price for the medication and receive no benefit from the rebate.
“If it isn't considerably cheaper to the patient and society, there is no value in using a biosimilar,” he emphasized.
Dr. Kay responded that the objective of biosimilar development is to establish biosimilarity, not to re-establish benefit. Biosimilars undergo a thorough regulatory approval process with extensive analytical studies and an abbreviated clinical program. Therefore, a biosimilar approved according to a regulatory pathway for biosimilars should be as safe and effective as the reference product.
“If the actual cost of a biosimilar is not lower than that of its reference product after discounts and rebates, the availability of the biosimilar introduces market competition that results in effective treatment for patients with the reference product at a lower cost,” he concluded.
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Furst DE, Solomon DH, Kay J, Fleischmann R. Great debate: Biosimilars…To switch or not to switch? That is the question. Presented at: 2017 ACR/ARHP Annual Meeting; November 3-8, 2017; San Diego, California. Scientific Sessions 3S081.