ACR ‘poised to reconsider’ position on biosimilars
medwireNews: The American College of Rheumatology (ACR) has issued a white paper recommending the use of biosimilar agents, when appropriate, for the treatment of rheumatologic diseases.
The authors of the white paper, led by S Louis Bridges Jr (University of Alabama at Birmingham, USA), provide an overview of biosimilars, including the nomenclature, pathways for their approval, and guidance from US and European regulatory agencies on extrapolation of indications and switching.
Although the ACR initially supported the development of biosimilars, the organization “urged caution as they were being developed, evaluated, and approved,” say the authors.
However, “[n]ow that biosimilars have been used successfully in Europe, with rigorously acquired data supporting their broader use, and as the US is on the verge of a similar transition, the ACR is poised to reconsider its position,” they write in Arthritis & Rheumatology.
Bridges Jr and colleagues recommend that healthcare providers should “maintain a working knowledge” of the approved biosimilars, and monitor developing policies and guidelines on the use of new and existing agents.
The authors note that the degree to which biosimilars will drive down the cost of biologic therapy remains to be seen, but they “remain optimistic that the use of biosimilars will improve patient access to biologic agents, allowing continued delivery of high-quality health care to be realized at a lower cost to the individual patient.”
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