WASHINGTON – U.S. Senator Mike Lee (R-UT) introduced the bipartisan Biosimilar Red Tape Elimination Act today to cut drug prices for consumers and increase competition in the pharmaceutical market by categorizing generic-brand “biosimilar” drugs as interchangeable with their name-brand counterparts. Senators Rand Paul (R-KY), Maggie Hassan (D-NH), and Ben Ray Luján (D-NM) cosponsored the legislation.

“Americans are missing out on lower drug prices thanks to bureaucratic red tape that protects big pharma monopolies,” said Senator Mike Lee. “Many consumers would choose a cheaper generic-brand version of their medications, but technicalities from Congress have kept these out of reach. Our legislation will cut the red tape to bring drug prices down, break up the big pharma monopolies, and let Americans make their own medication choices.” 

“I’m proud to support Senator Lee’s Biosimilar Red Tape Elimination Act. Americans pay too much for prescription treatments because of outdated FDA requirements. This bill would give pharmacists more options, subject to state law, to substitute unaffordable therapeutics with lower-cost alternatives. I offered similar reforms in the past because health care reform starts with giving patients more affordable choices. It’s time we stop letting red tape stand between patients and lower prices.” said Dr. Rand Paul

“Too many Americans face sky-high prescription drug costs. This bipartisan legislation will cut unnecessary red tape and help biosimilar drugs get to the market faster, creating more competition in the market, and cutting costs for consumers,” said Senator Hassan. “I will continue to work to lower prescription drug and health care costs for Granite Staters and all Americans.”

“Limited competition drives up drug prices, making it harder for people to afford the medications they need to survive. Expanding access to biosimilar drugs can improve patients' lives and reduce costs. But too often, access can be limited due to regulatory red tape that scientists agree is not necessary,” said Senator Luján. “This bipartisan bill will help simplify that process while maintaining rigorous safety and effectiveness standards. By increasing competition, this legislation will allow more patients and families to access the treatments they need.”

“As the FDA has made clear, there is no clinically meaningful difference between biosimilars and interchangeable biosimilars,” said John Murphy, President and CEO of the Association for Accessible Medicines. “The Biosimilar Red Tape Elimination Act will expand competition and generate savings for patients and taxpayers, while preserving FDA’s ability to ensure the safety and efficacy of medicines for America’s patients. The Biosimilars Council and AAM thank Senators Lee and Luján for their work on behalf of American patients and we look forward to working with Congress to eliminate this outdated and unnecessary barrier to lower-priced biosimilar medicines.”

Background:

“Biosimilars” – generic alternatives to name-brand medications – have the potential to significantly reduce the cost of biologic drugs through increased competition. Choosing biosimilars over their name-brand counterparts could save consumers an estimated $42.9 billion by 2027. Americans deserve to hold this decision-making power, but red tape around biosimilars keeps them from being widely used. The FDA’s complex approval system has confused physicians, patients, and states about biosimilars’ safety and efficacy.

Biosimilars must undergo extensive testing to prove they provide no meaningful difference from their name-brand version. Bringing a new biosimilar to market costs as much as $300 million and can take as long as 9 years. Even after this approval, patients may not be able to access biosimilars because Congress created a separate designation: interchangeability. To be classified as truly “interchangeable” with the name-brand version, a biosimilar must undergo further testing called “switching studies.” This type of research has proven unnecessary for biosimilars, as it repeatedly shows no meaningful difference or relevant new data. 

The Biosimilar Red Tape Elimination Act would remove these extra steps so that a biosimilar will immediately be classified as interchangeable upon its initial approval by the FDA. Foregoing unnecessary switching studies would no longer disqualify biosimilars as alternatives to their name-brand counterparts. 

This legislation will streamline the regulatory pathway for biosimilar approval by aligning the law with the current scientific reality, giving Americans the option to save billions and increasing competition in the pharmaceutical market.

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 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.