Biosimilars: The Time to Be Proactive Is Now (English Edition)

As biosimilars enter the U.S. marketplace, health-system pharmacists will be asked to take prudent measures as they consider and evaluate these therapies for substitution into their formularies. Pharmacists can seize the intervening time to assume leadership positions in preparing their organizations and clinical colleagues for the continued development of this new product class. Additionally, they can ensure that an appropriate clinical infrastructure will be in place to allow for the safe and effective prescribing, administration, and monitoring of biosimilars. This monograph provides an update on the introduction of biosimilars in the United States, FDA draft guidance documents, state legislative activity regarding substitutability, and issues related to biosimilar naming and interchangeability with reference products.