Biosimilars: Beginning a Conversation

In 2010, the Biologics Price Competition and Innovation (BPCI) Act was passed under the Patient Protection and Affordable Care Act (FDA, 2010). It created an abbreviated pathway for the approval of biologic products demonstrated to be clinically similar (or biosimilar) to or interchangeable with an approved reference product. A diverse panel of experts convened at JADPRO Live at APSHO to discuss key requirements for interchangeability and potential roadblocks to US Food and Drug Administration (FDA) pathways for the approval of biosimilars. Panel moderator Christopher J. Campen, PharmD, BCPS, BCOP, clinical pharmacist, Greenville Health System, Greenville, South Carolina, kicked off the discussion by asking why the United States lags behind Europe in bringing biosimilars to market. Kelley D. Mayden, MSN, FNP, AOCNP®, nurse practitioner, Wellmont Cancer Institute, Bristol, Virginia, cited incomplete draft guidance from the FDA. As a result, she said, the pharmaceutical industry “didn’t really understand exactly what was expected,” and further had to evaluate whether the biosimilar market was lucrative enough to invest in. The FDA took the stance that it didn’t have the unilateral authority to create a biosimilar pathway, so it was dependent on legislation, “and that took a long time because that’s the way Washington, DC, works,” commented Michael Swit, Esq, Senior Director, Legal, Regulatory at Illumina, Inc., San Diego, California. “The FDA never wants to issue a regulation if they don’t have to because it becomes binding on them. So they issue guidance documents, and that takes a long time, in part because you don’t have user fees associated with the whole biologic process.” Regulatory and pricing issues initially held back the biosimilar market in the United States, but the pathway to approval guidance from the FDA has improved over the past 5 years, according to Ali McBride, PharmD, BCPS, BCOP, Clinical Coordinator, University of Arizona Cancer Center, Tucson.