In a recent column for TheJournal of Healthcare Contracting, Healthcare Supply Chain Association (HSCA) President Curtis Rooney writes that the approval of the first biosimilar—a biologic drug that is highly similar to its reference product—in the United States marks the beginning of a new era in American healthcare. Rooney explains that biosimilars have the potential to increase patient access to innovative therapies while also reducing costs for the healthcare system.
Rooney notes that several companies currently have biosimilar applications under review by the U.S. Food and Drug Administration (FDA), and then details the specific guidance documents the U.S. Centers for Medicaid and Medicare Services (CMS) and FDA have released as these drugs come to market.
Rooney also outlines HSCA’s position on biosimilars in the piece:
Biosimilars should share the same International Nonproprietary Name (INN) as their reference biologic;
FDA should issue clear guidance on the requirements to obtain an “interchangeable” designation;
States should support a pathway for the expedient and safe implementation of biosimilars as soon these drugs are approved.
To read the full piece in The Journal of Healthcare Contracting,click here
To read HSCA’s policy position on biosimilars,click here.