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WASHINGTON, DC — Today, Representatives August Pfluger (TX-11) and Greg Landsman (OH-01) 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 For far too long, unnecessary barriers and outdated FDA requirements have prevented Americans from accessing a less expensive, generic version of their medication.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.

"Healthcare needs real reform, and we can start by making prescription drugs more affordable for everyone. Outdated rules are keeping lower-cost drugs off the market, and our families are paying the price. This bill will allow innovative drugs to come to market faster and cheaper, and allow pharmacists to swap higher-cost prescriptions for safe and effective alternatives – lowering costs at the pharmacy counter and saving folks real money," said Rep. Landsman

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.

Read the full text of the legislation 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.

Rep. Pfluger's legislation is also supported by several outside organizations that released the following statements of support:

Julie Reed, executive director of the Biosimilars Forum, said, “Biosimilars have saved the U.S. healthcare system $56 billion with the potential to save an additional $181 billion in the next five years. The Biosimilars Forum and I would like to thank Representative Pfluger for working to improve access to lower-cost biosimilars to Americans who need them by eliminating unnecessary burdensome studies. The biosimilars industry and the FDA have a decade of experience developing and approving more than 70 biosimilars. Outdated and unnecessary steps delay biosimilar development and prevent Americans from accessing lower-cost medicines they need.”

Alex Keeton, Executive Director of the Biosimilars Council and Senior Vice President of Policy, said, "The Biosimilars Council and the Association for Accessible Medicines thank Representatives Pfluger and Landsman for their work on behalf of American patients, and we look forward to working with House and Senate cosponsors to eliminate this outdated and unnecessary barrier to lower-priced biosimilar medicines. There is no clinically meaningful difference between biosimilars and interchangeable biosimilars. The Biosimilar Red Tape Elimination Act will expand competition and savings for patients and taxpayers, while preserving the FDA’s ability to ensure the safety and efficacy of medicines for America’s patients."

Lauren Aronson, Executive Director, Campaign for Sustainable Rx Pricing, said, "CSRXP applauds Representatives Pfluger (R-TX) and Landsman (D-OH) for introducing the Biosimilar Red Tape Elimination Act to support greater competition and lower prescription drug prices for patients. This bipartisan, market-based solution will modernize outdated policies and remove unnecessary regulations, helping to bring more affordable alternatives to high-priced brand-name drugs to market more quickly. We encourage lawmakers in both chambers to advance this solution to help lower prescription drug prices for American patients and taxpayers by fostering greater biosimilar competition."

Background:

“Biosimilars” are generic alternatives to name-brand medications and have the potential to significantly reduce the cost of drugs by increasing 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.