The Biosimilar Red Tape Elimination Act
The Biosimilar Red Tape Elimination Act (S.1954) allows pharmacists to automatically substitute a prescribed brand-name drug with its lower-cost biosimilar alternative (where allowed by state law), saving you money on out-of-pocket costs without needing a new prescription from your doctor.
This legislation would make it possible to get high-quality, lower-cost alternative medications to the market and into patients’ hands faster. Biosimilars must still meet strict Food and Drug Administration (FDA) standards to prove they are just as safe and effective as the original brand-name drug before they can be sold.
Ultimately, if passed, the Biosimilar Red Tape Elimination Act (S.1954) would:
- Deem all FDA-approved biosimilar biological products (such as drugs or vaccines) automatically interchangeable with their original reference products without requiring separate, additional interchangeability studies (e.g., switching safety studies).
- Allow pharmacists to automatically substitute a biosimilar for a prescribed reference product (subject to state laws), helping lower out-of-pocket costs for patients.
- Preserve the marketing exclusivity period for any “first interchangeable” biosimilar licensed before the bill’s enactment.
- Lower out-of-pocket expenses by driving pharmacy-level competition, across the board, and reducing copays.
This legislation allows for greater access to alternative, more cost-effective therapies with equivalent safety and efficacy outcomes for patients, where available, without additional administrative burden.
Join us in our advocacy in support of this bill by reaching out to your lawmaker today!
