FDA Hearing Explores Competition & Innovation in Biosimilars
September 7, 2018
When it comes to how to increase the development and utilization of biosimilars, the Food and Drug Administration is all ears. On Tuesday, the agency welcomed numerous physicians and experts to testify on competition and innovation in the biosimilars marketplace. And at least one physician identified a critical component in uptake: physician confidence.
“Biosimilars can provide still more treatment options, more choices for patients and physicians,” explained David Charles, MD, national chairman of the Alliance for Patient Access. “But for that, we need biosimilar uptake. And to achieve uptake, we need physicians to have the fullest confidence in biosimilars.”
Dr. Charles used his public comments to identify two elements essential to earning physicians’ confidence in biosimilars, particularly when substitution may occur:
- Rigorous testing. “Allowing pharmacists to swap an interchangeable biosimilar with its reference product without the prescribing physician’s involvement suggests utter confidence in the therapies’ similarities,” Dr. Charles noted, adding, “It demands thorough evidence.” In particular, Dr. Charles emphasized the importance of multiple switches during clinical trials of interchangeable biosimilars to ensure that the data reflect real-world use.
- Data transparency. Dr. Charles also encouraged ready access to complete information about how multiple switches affect patients’ response to treatment, the toll it takes on their immune systems and the impact it has on a therapy’s efficacy. “Physicians are scientists by training,” Dr. Charles reminded regulators. “As such, we find confidence in the data. Plain and simple, physicians want proof.”
Together, rigorous testing and data transparency can help engender physician confidence, which can increase biosimilar uptake and expand treatment options for patients.
The FDA issued draft guidance on biosimilar interchangeability in January 2017 but has not yet finalized it. No biosimilar has yet been designated interchangeable.
To learn more about biosimilars’ promise and interchangeability, watch the Alliance for Patient Access’ “The Interchangeability Promise.”
Tags: Biologics, Innovation, Regulatory Issues
Categorized in: Blog