The FDA is considering changes to its biosimilar policy, which could benefit companies that develop complex follow-on biologic drugs, clinicians who prescribe them, and the patients who receive them. Currently, pharmacists cannot substitute lower-cost biosimilars for brand-name products unless they are classified as interchangeable by the FDA. This requires additional clinical trials beyond those needed for initial FDA approval. The FDA recently released draft guidance stating that switching studies may not be necessary for biosimilar developers seeking interchangeability status, reducing time and expense. Senator Mike Lee has previously introduced legislation to eliminate the switching studies requirement, aligning the U.S. with the European Medicines Agency’s approach to biosimilar interchangeability. The FDA is seeking public feedback on these proposed changes until Sept. 20.
June 21, 2024
Artificial Intelligence
FDAcop
