Biosimilar Elimination Red Tape Act
In November 2022, Sen. Mike Lee (R-UT) introduced the Biosimilar Elimination Red Tape Act that would prohibit the FDA from requiring that biosimilars undergo switching studies. Currently, FDA-approved biologics must have a separate study that demonstrates no clinical difference in health outcomes compared to the reference biologic to receive an “interchangeable” designation. The bill portrays the required studies as a barrier to bringing cost-saving biosimilars to market in a meaningful way. If passed, the faster pathway could have a significant impact on the competitive landscape.
The likelihood of passage remains unknown with a divided Congress in 2023, but life sciences companies should be prepared to address the potential implications of the proposed measures.
- The US is the only country with two classes of biosimilars: interchangeable and non-interchangeable; an interchangeable status.
- This designation is mandated in the Biological Price Competition and Innovation Act (BPCIA), which is part of the Affordable Healthcare Act.
- Many state laws prohibit pharmacists from switching prescriptions for biologics with an FDA-approved biosimilar unless the FDA declares the biosimilar is interchangeable.
- To date, the FDA has granted the interchangeable status to only four of the 39 biosimilars it has approved.
Why this matters:
- Biologic drugs make up approximately 46% of U.S. prescription drug spending, despite only making up 0.4% of prescriptions.
- Biosimilars are expanding into new areas: Growth seems to be on the horizon for the marketplace with biosimilars. As of Q2 2022, the FDA lists 96 proposed biosimilar products enrolled in the FDA’s Biosimilar Development Program, an increase of more than 70% since October 2015.
- The next few years will likely see several advancements, including expansion of biosimilars into pharmacy benefit reimbursement and biosimilars entering more classes, as well as additional approvals and launches of interchangeable biosimilars in the U.S.
What life sciences companies can do:
- Life sciences companies should closely monitor the FDA’s listof licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations and update 2023 scenario plans accordingly.
- Develop messaging on the emerging role of biosimilars in US and ex-US markets, including whether companies believe switching studies offer a patient benefit and should continue to be required.
- Refine value narratives and anticipate tough Q&A to account for any potential impact – to therapy and portfolio – biosimilars may have on the competitive landscape.
- Support state-level government affairs teams with a value and access external communications strategy, including messaging on the switching studies.