Illustration: Sarah Grillo/Axios
A biosimilars bill due to be marked up in the Senate HELP Committee on Thursday marks the latest step in congressional efforts to make it easier to swap the products for brand-name biologics to address high drug prices.
Why it matters: If approved, it would allow biosimilars to be deemed interchangeable with their brand-name equivalent once the biosimilar is approved by the FDA, and it would loosen requirements for switching studies.
- The bill mimics a proposal included in President Biden's FY25 FDA budget and also follows recent FDA guidance on interchangeability.
The intrigue: The Biosimilar Red Tape Elimination Act shows how some Republicans are eager to take on brand-name drugmakers in certain areas and is cosponsored by conservative Sens. Mike Lee, Mike Braun, JD Vance and Rand Paul along with Democrat Ben Ray Luján.
- The drug industry opposes the measure, saying it would do away with important scientific standards and help PBMs shift patients to medicines that would boost their profits.
What they're saying: "Biosimilars would be the biggest immediate solution to high pharma health care costs," Braun told Axios.
- "Pharma companies constantly tweak [biologics] to make them either delayed coming to the marketplace or just difficult to have them as a generic option," he added, noting that the bill would discourage efforts to game the system.
- A Lee aide told Axios that it's the first time the bill has been slated for markup and that there may be unspecified tweaks to work out with committee staff.
- The Biosimilars Council has urged senators to pass the bill, stating that "it will help ensure generic and biosimilar savings."
The other side: Meanwhile, in opposing the legislation, PhRMA says it's "a concerning departure from the current standards for demonstrating and FDA flexibility in determining biosimilar interchangeability."
- "The bill would do away with important safeguards that protect patient safety without addressing the anticompetitive behavior by pharmacy benefit managers that block access to biosimilars and allow them to profit from medicines at the expense of patients," said Andrew Powaleny, a senior director of public affairs at PhRMA, in a statement.
Catch up quick: The FDA issued draft guidance this summer stating that biosimilar manufacturers don't necessarily have to provide switching studies for their biosimilars to be deemed interchangeable with the reference product.
- Switching studies are when a patient alternates between taking the biosimilar and the brand-name biologic to confirm they're interchangeable.
- A version of this was also included in Biden's FY25 FDA budget, in which the agency proposed getting rid of the statutory distinction between the approval standard for biosimilars and interchangeable biosimilar products.
- In the proposal, the FDA noted that this would "make the U.S. biosimilar program more consistent with current scientific understanding" and the "approach adopted by other major regulatory jurisdictions such as the European Union."
What's next: With the Senate expected to leave town after passing a government funding patch Wednesday, it's unclear whether the HELP markup could be postponed.
- But the bill is likely to come up after the election, along with a narrow patent reform bill also aimed at reducing high drug prices.
