Biosimilar Products in the Modern U.S. Health Care and Regulatory Landscape

Biosimilars have the potential to greatly reduce medication costs in the United States. As of July 1, 2017, 5 biosimilars have been approved by the FDA, but only 2 are available for purchase. This commentary outlines the efforts of an integrated health system to ensure biosimilar accessibility and discusses the current challenges and future implications. We highlight the implementation of a health plan policy and how a health system's formulary committee can encourage use while considering provider perceptions and operational challenges. In addition, we provide our perspective on potential implications for pricing, site of care, and pharmacy dispensing practices based on our experience with regulatory hurdles and market trends. Overall, we believe biosimilars are a good thing for the health care system, but their expected benefit may not be realized for years to come.

No outside funding supported this work. Affeldt reports advisory board membership with Janssen, and Skiermont reports membership with Amgen and McKesson. The other authors have nothing to disclose. Peterson and Budlong contributed the study concept and design and wrote the manuscript. Affeldt, Skiermont, Kyllo, and Heaton reviewed and revised the manuscript.