Expedited Access to Biosimilars Act aims to streamline the approval process for biosimilar biological products by limiting clinical studies.
The Expedited Access to Biosimilars Act amends the Public Health Service Act to change the default expectation for the licensure of biological products as biosimilars. It specifies that clinical studies assessing pharmacodynamics or comparative clinical efficacy are not required by default. The Secretary of Health and Human Services may only require such studies if they are deemed necessary to demonstrate biosimilarity, with written notice provided to the sponsor. This change aims to expedite the approval process for biosimilar biological products.
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- Overview
- Core Provisions
- Implementation
- Impact
- Legal Framework
- Critical Issues
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