Expedited Access to Biosimilars Act
To amend the Public Health Service Act to codify that the default expectation for licensure of biological products as biosimilar does not include clinical studies assessing pharmacodynamics or comparative clinical efficacy, and for other purposes.
This bill, HB9661, proposes changes to how biological products, often referred to as biosimilars, are approved by the government. Currently, the process of approving these products involves detailed studies to understand how they work and how they compare to existing treatments. HB9661 aims to change this by making it the standard that such detailed studies are not required unless specific conditions are met.
If passed, this bill would mainly affect pharmaceutical companies and healthcare providers by potentially speeding up the approval process for new biosimilar products. This could mean more treatment options become available faster, but it also raises questions about the thoroughness of the approval process.
HB9661 was introduced on July 14, 2026, and was referred to the House Committee on Energy and Commerce the same day. This means it is now under review by the committee, which will decide whether to move it forward to a vote by the full House. The bill is in its early stages, and significant actions and discussions are yet to come.
