“The ACR’s white paper on biosimilars will inform prescribers about the FDA approval process, scientific and clinical issues, such as extrapolation, immunogenicity, switching and interchangeability; and issues related to cost, access and the mechanics of prescribing,” Dr. Worthing says. “The purpose of the white paper is to inform our members about biosimilars, reassure them about the scientific rigor used by regulatory authorities and boost confidence in prescribing biosimilars.”
As of publication, this paper was still in draft form.
Vanessa Caceres is a medical writer in Bradenton, Fla.
- European Medicine Agencies and European Commission. Biosimilars in the EU: Information guide for healthcare professionals. 2017.