Yesterday, Senators Lee (R-UT) and Luján (D-NM) reintroduced the bipartisan Biosimilar Red Tape Elimination Act—a long overdue solution to a regulatory bottleneck that limits patient access to safe, effective and lower-cost biologic therapies.
The commonsense bill does a simple but powerful thing: it removes outdated Food and Drug Administration requirements that block approved biosimilars from being automatically substituted for brand-name biologics at the pharmacy counter, just like generic drugs are today.
Under current law, biosimilar manufacturers, in general, must conduct costly and time-consuming “switching studies” once their product has been approved just to earn an “interchangeable” designation. But these studies are scientifically redundant as the evidence has already shown that there is no meaningful difference in safety, efficacy, or clinical outcomes when switching to the biosimilar product. Further, since the first biosimilar approval by the FDA nearly a decade ago, both experience and advances in analytical technology have shown that potential differences between biosimilars and their reference products can be assessed through streamlined regulatory assessments without relying on this extra, costly, and time-consuming step. Even the FDA has acknowledged that the scientific standard for biosimilars and interchangeable biologics is the same and has recommended that Congress eliminate the statutory distinction between the two.
Backed by the FDA’s own FY 2025 legislative recommendation, this bill aligns U.S. policy with trusted global markets like the European Union, where all approved biosimilars are considered interchangeable from day one. And, importantly, this bill preserves FDA oversight, allowing the agency to require switching studies if needed.
The stakes are huge. Since their U.S. debut in 2015, biosimilars have saved our healthcare system $36 billion, and that’s despite unnecessary barriers slowing adoption. The Biosimilars Red Tape Elimination Act would unlock even more savings by boosting biosimilar competition and improving patient access.
But not everyone wants this change. Big pharma is fighting back, spreading misinformation to protect monopolies. Here’s the truth: biosimilars are safe, effective, and critical to fixing our broken drug pricing system. The Biosimilars Red Tape Elimination Act is a common-sense step toward aligning policy with science, empowering patients, and prioritizing affordability over profit.
Congress must act now. It’s time to cut the red tape, clear the path for biosimilars, and ensure American patients can access the life-saving medicines they need … at a price they can afford.
