Category: Biologics and Biosimilars

  • Ensuring timely reauthorization of PDUFA and BsUFA

    Today, the House Energy and Commerce Subcommittee on Health will be hosting a markup session on the comprehensive legislative package to reauthorize the human drug user fee programs, including the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Act (BsUFA III). In February, PhRMA had the opportunity to testify before the […]

  • The accelerated approval pathway: Helping patients with serious or life-threatening diseases

    Today, the House Energy & Commerce Committee’s Subcommittee on Health will meet to discuss policy proposals to “encourage innovation and improve oversight” regarding medical innovation. This hearing comes at the same time members of Congress are considering the reauthorization of the user fee programs, the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar […]

  • The importance of timely PDUFA and BsUFA reauthorization

    Today, PhRMA, along with the U.S. Food and Drug Administration (FDA) and other industry trade associations, will be participating in a congressional hearing with the House Committee on Energy and Commerce Subcommittee on Health discussing the user fee programs which are under consideration by policymakers for reauthorization this year. This follows the U.S. Department of […]

  • How strengthening the biosimilar marketplace benefits patients

    Biologics are medicines that are made from living organisms through highly complex manufacturing processes and include a wide variety of medicines such as therapeutic proteins, monoclonal antibodies and vaccines. They are used to prevent or treat a variety of diseases including cancer, chronic kidney disease, diabetes, cystic fibrosis and autoimmune disorders.