Senate bill proposes faster review process for biosimilar drugs
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Table of Contents
This bill would change the Public Health Service Act to alter how the FDA reviews biosimilars. A biosimilar is a biological product that is highly similar to a brand-name drug already approved by the FDA.
Why it matters: This is a procedural change intended to make it easier and faster for manufacturers to get biosimilar drugs approved. Whether this actually results in faster approvals depends on how the FDA implements the new rules.
Who it affects
- Pharmaceutical companies that manufacture biological products
This information comes from Congress.gov regarding a Senate bill; please consult the official text before relying on this information.
Agency: Senate
Source: Congress.gov — read the official document