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Draft FDA Guidance No Longer Requires Biosimilar Switching Studies

From the College  |  August 17, 2024

The ACR is fiercely dedicated to ensuring that guardrails remain in place for patient safety when switches occur. ACR/ARP members should email the ACR’s advocacy team at [email protected] with any questions and comments they may have. We will monitor the rule’s implementation and serve as an educational resource for members on its provisions and the impact they will have on rheumatology.

Read the ACR’s comments on this proposal to the FDA.

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Reference

[1] Focus on interchangeable biosimilars. The American Pharmacists Association. 2024.

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Filed under:GuidanceLegislation & Advocacy Tagged with:Biosimilarsinterchangeability

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