Today, Representatives August Pfluger and Greg Landsman introduced legislation to lower prescription drug prices for Texans and ensure everyone has affordable access to the medication they need. The bipartisan, bicameral Biosimilar Red Tape Elimination Act would improve patient access to lower-cost prescription medications and increase competition in the biological drug market by automatically deeming “biosimilar” drugs as interchangeable with their name-brand counterparts upon FDA approval.
“Our healthcare system is unfortunately marked by skyrocketing costs, especially when it comes to prescription drugs. For far too long, unnecessary barriers and outdated FDA requirements have prevented Americans from accessing a less expensive, generic version of their medication. Our legislation is a simple, commonsense step we can take to ensure Texans keep more of their hard-earned money by eliminating this burdensome red tape that disincentivizes competition and drives prescription drug prices up for all patients," said Rep. Pfluger.
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 FDA to issue or retract relevant guidance.
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