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However, the degree to which biosimilars will drive down the cost of biologic therapy remains to be seen.
A recent white paper from the American College of Rheumatology (ACR) encourages clinicians to incorporate biosimilars into the treatment plans of patients with rheumatic diseases, where appropriate.1,2
The FDA has approved 9 biosimilars, 6 of which are for treatment of rheumatic diseases, since the Biologics Price Competition and Innovation Act of 2009 was passed in an effort to reduce costs and increase patients' access to biologics. As biosimilar use increases, an extensive discussion about immunogenicity, switching, and patient access has emerged.
New recommendations for clinical practice have been made, based on continued evaluation from regulatory agencies and successful administration of biosimilars in Europe. Over the past few years, the ACR has voiced its support for FDA approval measures to ensure the safety of biosimilars as they become available in the US market, including a proposal to require manufacturers to use robust switching studies and support for distinct naming conventions and billing codes to make post-marketing surveillance easier.
"The ACR has closely followed the development, evaluation, and approval processes for biosimilar agents, in addition to observing their successful use in other countries," said Dr. S. Louis Bridges, Jr., MD, PhD, chair of the ACR's Committee on Research and lead author of this paper. "We are now confident that providers can recommend biosimilars as a safe, effective, and affordable option to patients, where appropriate."
The authors note the only anticipated advantage of a biosimilar over its reference product is lower cost, given that the 2 drugs should be therapeutically equivalent, and that biosimilars could play a crucial role in fostering competition that keeps high drug prices at bay. However, the degree to which availability of biosimilars in the US will drive down the cost of biologic therapy remains to be seen. Obstacles for patient accessibility include drug copayments for biosimilars that are nearly as expensive as those for the reference drug.
"There are a variety of market-based and legislative factors that contribute to the accessibility of biosimilars," said Dr. Angus Worthing, MD, chair of the ACR's Government Affairs Committee and co-author of the white paper. "While we have yet to see broad cost-saving benefits in the US 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."
1. American College of Rheumatology recommends biosimilar use in new white paper [press release]. Atlanta, Georgia: American College of Rheumatology. Published February 7, 2018. Accessed February 15, 2018.
2. Bridges SL, White DW, Worthing AB, et al. The science behind biosimilars: entering a new era of biologic therapy. [Published online February 7, 2018]. Arthritis Rheumatol. doi: 10.1002/art.40388