Luján, Lee, Braun, Vance Introduce Bipartisan Legislation to Increase Biosimilars in Drug Market

Washington, D.C. – U.S. Senators Ben Ray Luján (D-N.M.), Mike Lee (R-Utah), Mike Braun (R-Ind.), and J.D. Vance (R-Ohio) introduced the Biosimilar Red Tape Elimination Act, bipartisan legislation to increase the biological drug market, expand access to low-cost prescription drugs, and ultimately lower drug prices for patients. The Biosimilar Red Tape Elimination Act deems biosimilars as interchangeable with their branded equivalent upon its approval by the Food and Drug Administration (FDA). 

Biosimilars are the generic equivalents of biological brand-name drugs and have the potential to significantly lower drug costs through increased competition. Unlike Europe, where there is no interchangeability designation and analysis, a two-step process unique to the United States keeps many drug sponsors from gaining an “interchangeability” designation. After the first FDA approval of a biosimilar that shows equivalency with the reference biologic, drug sponsors need to conduct costly and time-consuming additional studies to be deemed interchangeable. Fifteen years of approvals show that there is no significance evidence that these additional studies risks immunogenicity which are detrimental to human health.

A biosimilar that is not deemed interchangeable faces major impediments to physician and patient confidence in biosimilars. For example, many states will not allow pharmacists to substitute biosimilars despite their equivalency. As of May 2023, the FDA has approved 41 biosimilars, but has only granted interchangeability to four. The lack of interchangeable biosimilars hinders the availability of affordable pricing options for patients. Eliminating the additional designation of interchangeability to biosimilars will increase access to lower-cost medicine and save patients billions in health care costs.

“Utilizing more biosimilar drugs will benefit patients and lower drug costs. But access is often limited because of the unique drawn-out process. This bipartisan legislation will streamline the approval process while maintaining patient safety and effectiveness. This change will help increase competition in the marketplace to ensure more patients and their families have access to medication that help treat diseases and other chronic conditions.” said Senator Luján. 

“Our current regulatory environment imposes onerous and costly burdens that hinder the entry of biosimilars into the market. Ultimately, it’s the patients who bear the brunt of limited competition and exorbitant drug prices. We owe it to them to break down these barriers and ensure they have timely access to these life-changing drugs.”said Senator Lee. 

“When there’s a lack of competition in the market, it’s the patients that suffer. In the Senate, I’ve been committed to expanding transparency and competition in the healthcare industry and this legislation would save Americans money by making sure that more biosimilars make it to market,” said Senator Braun. 

“Biosimilars are an important part of lowering the cost of prescription drugs and are on track to save Americans tens of billions of dollars over the next five years. This bill by Senators Lujan and Lee will help cut red tape and safely bring more of these medications to market to create competition and lower prices.  We are proud to endorse and hope Congress will act on this vital legislation,” said Margarida Jorge, Campaign Director, Lower Drug Prices Now.

A summary of the bill can be found HERE. Full text of the bill is available HERE.

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