Bill > S1414

This bill amends the Public Health Service Act to modify the clinical study requirements for biosimilar drug approvals. Specifically, the bill allows pharmaceutical companies to more easily obtain approval for biosimilar drugs (which are similar to, but not exactly the same as, existing biologic drugs) by reducing mandatory clinical study requirements. Under the new provisions, companies would not automatically be required to conduct comprehensive studies assessing immunogenicity (how the body's immune system responds to the drug), pharmacodynamics (how the drug interacts with the body), or comparative clinical efficacy (how the drug performs compared to the reference product). Instead, the Food and Drug Administration (FDA) would have discretionary power to request such studies, but would be required to provide a written justification if additional testing is deemed necessary. This change is intended to streamline the approval process for biosimilar drugs, potentially reducing development costs and bringing these more affordable alternatives to market more quickly. The amendments would apply to all biosimilar drug applications submitted on or after the date of the Act's enactment.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/1414/all-info