Biosimilar Drugs: Faster Approval Process
A senate committee must act next: committee consideration.
While lowering drug costs is popular, removing safety testing requirements often faces pushback from health advocates and the medical community.
Scores run from -100 (strongly harmful) to +100 (strongly beneficial) for each group, combining impact, certainty, scope, and duration ratings of 1-5. How impact scoring works
Smaller biotech and biosimilar developers often face high costs from large clinical trials required to prove similarity to brand-name biologics. Reducing default testing requirements could lower the cost of bringing a biosimilar to market, making it more feasible for smaller firms to compete with large drugmakers.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Sent to a congressional committee for expert review. The committee decides whether this bill moves forward.
Introduced in Senate
The bill was officially filed and given a number. It now enters the legislative queue.
Proposals in the House and Senate, both titled the Expedited Access to Biosimilars Act, seek to officially remove the FDA's requirement for clinical efficacy studies. The bipartisan House bill (H.R. 9661) would codify regulatory changes to comparative trial expectations.
During a Senate hearing, FDA Commissioner Marty Makary questioned the need for confirmatory trials for biosimilars, noting they are not required for generics. He expressed support for Senator Rand Paul's Expedited Access to Biosimilars Act to eliminate redundant study requirements.
The FDA issued draft guidance removing the routine requirement for comparative efficacy studies in biosimilar development. This shift reflects an agenda centered on accelerating drug development and modernizing review systems under Commissioner Makary.
No votes or related bills recorded for this bill yet.
Document Type
Congressional Bill
Official Title
Expedited Access to Biosimilars Act
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