The American College of Rheumatology (ACR) has published a position paper on the use of biosimilars in clinical practice. The new paper states that clinicians should now include biosimilars, where appropriate, to treat patients with rheumatic diseases.
The Food and Drug Administration (FDA) defines a biosimilar as a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. Minor differences between the reference product and the proposed biosimilar product in clinically inactive components are acceptable.
Initially, the ACR had concerns about the use of biosimilars, and urged clinicians to use caution when considering them for patients. “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,” the authors write. Given that there may likely be anxiety and skepticism associated with these new agents, the authors note the importance of communication between providers, pharmacists, and patients.
“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 access to these medications. It is also not clear that non-medical substitution will be effective in every patient nor has it been demonstrated that extrapolation is effective.” said Dr. Roy Fleischmann from the University of Texas Southwestern Medical Center and Metroplex Clinical Research in Dallas in a separate editorial.
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