The proposed legislation is welcomed by those in the biosimilar space and the FDA because for years the FDA has said that all biosimilar products, based on the current review and approval paradigm, should be considered interchangeable. The EU has adopted that position as well; however, this bill, if passed, will be the necessary legislative fix that will officially end any distinction between biosimilar approvals for the same reference product.
The legislation, introduced by Representatives August Pfluger (TX-11) and Greg Landsman (OH-01) and titled The Biosimilar Red Tape Elimination Act, would:
- Amend the federal code to state that all biosimilars, upon approval, shall be deemed interchangeable. The bill still uses the term “interchangeable” because states have crafted their own laws around interchangeability. Retaining that word would provide for minimal disruption to current biosimilar distribution.
- Strike the current requirement in the code that has been used to justify switching studies.
- Create a cooldown period for certain biologics that were already granted exclusive interchangeable status.
- Instruct HHS and the FDA to issue or retract relevant guidance.
The full text of the proposed legislation can be found here.
According to the release by Congressman Pfluger’s office (here), earlier this year, Senator Mike Lee (R-UT) introduced companion legislation in the Senate, and it was co-led by Senators Rand Paul (R-KY), Maggie Hassan (D-NH), and Ben Ray Luján (D-NM). Read more on Senator Lee’s legislation here.
If this bipartisan legislation passes, it will not only save consumers money but will also remove the stigma regarding biosimilar products not currently officially designated as interchangeable.
