A bill to require the Secretary of Health and Human Services to conduct a study on the designation of biosimilar biological products as interchangeable.

S 1522 requires the U.S. Department of Health and Human Services (specifically the FDA) to study how biosimilar biological products are designated as "interchangeable" (meaning pharmacists can substitute them for the original drug without a doctor's input). The study, due within four years, will examine challenges manufacturers face in getting this designation, the FDA's review process, data requirements for interchangeability versus standard biosimilars, and how the FDA uses real-world evidence. It will also compare FDA's interchangeability standards to the system for rating generic drugs. This study directly affects drug manufacturers seeking interchangeability designations and the FDA's regulatory approach. The report will inform future policy but does not change current law.