About this Initiative
This educational Initiative will provide an in-depth review of the various clinical and regulatory aspects concerning the eventual introduction of biosimilars in the United States. After considerable debate, recent legislation has provided a legal framework for the approval of biosimilars in the U.S. Although certain details of the regulatory process still need to be resolved and the first biosimilar may not be approved for another year or two, health care professionals will need to be educated about biosimilars in order to make sound policy and clinical decisions regarding their use.
Health care providers will play a major role in patient safety efforts once a biosimilar has been brought to the U.S. market through enhanced pharmacovigilance as well as education to policymakers, patients, and decision-makers in the health system. Physicians and pharmacists will need to knowledgeable regarding the unique characteristics of biologics, understand the developing regulatory system for biosimilars, and know which questions must be posed as biosimilars are considered.