The Biosimilar Red Tape Elimination Act aims to streamline the approval process for biosimilar biological products.
The Biosimilar Red Tape Elimination Act modifies the Public Health Service Act to improve the requirements for determining the interchangeability of a biological product with its reference product. It removes the need for a separate application for interchangeability and streamlines the approval process. The Act also mandates the Secretary of Health and Human Services to update guidance on reviewing and approving biosimilar biological products.
Included in complete analysis
- Overview
- Core Provisions
- Implementation
- Impact
- Legal Framework
- Critical Issues
See what it does, who it affects, and the critical issues in plain language. Free, 30 seconds.