The American College of Rheumatology (ACR) has published a position paper in Arthritis and Rheumatology to encourage healthcare providers to incorporate biosimilar drugs into treatment plans of patients with rheumatic diseases.1
The US Food and Drug Administration (FDA) has approved 6 biosimilar medications for the treatment of rheumatic diseases since the Biologics Price Competition and Innovation Act was passed in 2009 in an effort to reduce costs and improve access to biologic medications. The ACR has voiced its support for FDA measures enacted to ensure the safety of biosimilars, including its proposal to require manufacturers to use a controlled switching study to demonstrate interchangeability of a biosimilar with its reference product.2 The ACR also supports the use of distinct naming conventions and billing codes to make post-marketing drug safety 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,” stated S. Louis Bridges Jr., MD, PhD, chair of the ACR’s Committee on Research and lead author of the position paper. “We are now confident that providers can recommend biosimilars as a safe, effective, and affordable option to patients, where appropriate.”
The authors of the paper note that biosimilars usually cost less than the reference drug, which could foster competition to keep high drug prices in check. However, they add that the degree to which availability of biosimilars will drive down the cost of biologics remains to be seen. Patient access to biosimilars could also be affected by high drug copayments that are similar to the costs of the reference drug.
“There are a variety of market-based and legislative factors that contribute to the accessibility of biosimilars,” stated Angus Worthing, MD, chair of the ACR’s Government Affairs Committee. “While we have yet to see broad cost-saving benefits in the US marketplace, efforts from healthcare advocates, legislative measures, and the introduction of additional biosimilar options could help relieve the financial burden of patients using these therapies.”
- American College of Rheumatology recommends biosimilar use in new white paper [press release]. Atlanta, Georgia: American College of Rheumatology. https://www.rheumatology.org/About-Us/Newsroom/Press-Releases/ID/875/American-College-of-Rheumatology-Recommends-Biosimilar-Use-in-New-White-Paper. Published February 7, 2018. Accessed February 7, 2018.
- Bridges SL, White DW, Worthing AB, et al. The science behind biosimilars [published online February 7, 2018]. Arthrit Rheumatol. doi: 10.1002/art.40388