Illustration: Aïda Amer/Axios
The push in Congress to address high drug prices increasingly features calls for expanded access to biosimilars.
Why it matters: After years of lagging uptake, the lower-cost competitors to biologic drugs are gaining ground, especially for cancer and autoimmune conditions, with biosimilar spending expected to total as much as $49 billion by 2027.
- But their fate still hinges on doctors prescribing them and PBMs putting them on preferred formularies, which is where Congress comes in.
State of play: There's been action on a variety of bills this Congress aimed at making it easier to swap biosimilars for brand-name biologics.
- A Senate Finance Committee draft health care package last year would have required biosimilars to be included on certain formularies if the reference biologic was included, along with related measures. The language wasn't included in final version that was voted out of committee.
- The House Energy and Commerce committee unanimously endorsed a demonstration project that would enable doctors to get a share of the savings for prescribing biosimilars to Medicare patients.
- And the drug patent bill that the Senate hotlined in July would make it easier for biosimilars to reach the market by cracking down on manufacturers that take out multiple patents on the same product.
The FDA also issued a draft guidance this summer stating that biosimilar manufacturers don't necessarily have to provide switching studies for their biosimilars to be deemed interchangeable with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 reference drug to confirm they're interchangeable.
- Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars at the FDA, said the new recommendations "provide clarity and transparency about the FDA's thinking and align the review and approval process with existing and emerging science."
- In the Senate, Mike Lee and Ben Ray Luján are sponsoring legislation that would deem biosimilars interchangeable with their brand-name equivalent once the biosimilar is approved by the FDA. A version of this proposal was also included in President Biden's FY25 FDA budget.
What they're saying: Biosimilar trade associations argue that cracking down on certain PBM business practices could get even more biosimilars on formularies.
- "Patients and their families lose if they don't have access to lower-cost biosimilars," Juliana Reed, executive director of the Biosimilars Forum, wrote in a recent STAT op-ed. "PBMs have assured this loss across the board through a clear lack of access to biosimilars and denial of fair competition."
- We've been covering the PBM legislation circulating in Congress, but just as a reminder, a variety of bills include policies around delinking, spread pricing and transparency measures.
- "PBMs are actively advocating for policies that encourage even more competition in the prescription drug marketplace, with a special focus on supporting the entry and uptake of more affordable alternatives to high-priced brand name biologics," Greg Lopes, spokesperson at PCMA, said in a statement.
What they're saying: "There is definitely a lot of interest [in biosimilars] this Congress.… Probably the central reason is that folks are aware that if you're talking about savings and reducing spending on medicines, we have a track record of finding savings through biosimilars," Craig Burton, executive director of the Biosimilars Council, told Axios.
- "Folks have looked at biosimilars as kind of that next phase of savings … but that they're not yet delivering at the level that anyone would have hoped. And so I think we're now at a point where folks are kind of saying 'OK, why is that?'" Burton said.
Catch up quick: When the patent for AbbVie's blockbuster Humira expired last year, nine biosimilars were launched as alternatives.
- But reports showed slow uptake compared with Humira's sales.
- A variety of factors may be at play, including PBM placement on formularies and doctors not switching patients to the look-alike treatments.
- Several large PBMs have recently announced that they're expanding Humira's biosimilar coverage on their formularies.
- PCMA said that PBMs are supporting Humira biosimilars by recommending placement on drug formularies, and that "currently employers and health plans are often preferring the Humira biosimilars on formularies alongside the brand."
What we're watching: How biosimilars fare in the horse-trading around a year-end health package — and how the issue intersects with PBM delinking, spread pricing and transparency measures.
