Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Diversity
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

Biosimilars bill aiming to remove interchangeable requirement for pharmacy substitution reintroduced into US Senate

Jul 13, 2023

Senator Mike Lee reintroduced his Biosimilars Red Tape Elimination Bill into the US Senate, which – if implemented, will prohibit the FDA from requiring biosimilars to undergo switching studies to obtain ‘interchangeable’ designation.  Unlike small-molecule drugs, biosimilars cannot be substituted at the pharmacy level without this interchangeability designation. Sen. Lee’s bill would deem biosimilars as interchangeable with their branded equivalent upon their approval by the FDA.  

Sen. Lee previously introduced the bill on 17 November 2022.