Requirements for Biosimilars and Interchangeable Biological Drugs in the United States—in Plain Language

Abstract

After years of public debate, biosimilars and interchangeable biological products are closer to becoming reality for patients in the United States. President Obama’s health care reform bill amends the PHS Act to strike a balance between “innovation and consumer interests.” This article provides the highlights of this legislation and includes, among other topics, the accepted and established scientific and regulatory principles supporting decision making for these products; marketing exclusivity for the innovator’s reference product and the first approved interchangeable product; activities and timelines to foster communication to avoid lengthy discussion and court action in regard to patent infringement; and administrative issues, such as naming, guidance documents, and user fees.