Whitepaper The State of Biosimilars Policy: A White Paper from Biologics Prescribers Collaborative

The Biologics Prescribers Collaborative (BPC) believes biosimilars will play an increasingly important role in the U.S., providing patients and physicians with greater access to therapeutic options and cost savings. BPC serves as an educational resource to policy makers as they take actions to encourage the development of these medicines while protecting patient safety and the prescribers’ need for transparent medical data. By educating policymakers, BPC hopes to ensure that policies governing the approval and use of biosimilars are crafted carefully to include the latest science, reflect clinical best practice, and uphold patient safety. As prescribers of biologics, our unique and important perspective about their use is presented in this white paper, and we will continue to provide Congress and the Administration education to create the needed rigorous policy framework that will promote access to and safe use of biosimilars for the millions of patients in America who could benefit from these medicines.


Some of the key biosimilars issues discussed in this white paper include:

  • Naming
  • Interchangeability
  • Indication Extrapolation
  • Labeling
  • CMS Reimbursement
  • The Biosimilar User Fee Act (BsUFA)


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