The Biosimilar Red Tape Elimination Act amends the Public Health Service Act to improve the requirements for determining interchangeability of.
The Biosimilar Red Tape Elimination Act amends the Public Health Service Act to streamline the process for determining the interchangeability of biosimilar biological products. It removes the requirement for a separate application for interchangeability, instead deeming a biological product interchangeable with its reference product upon licensure. The Act also mandates the Secretary of Health and Human Services to update existing guidance on biosimilar products within 18 months of the Act's enactment.
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- Legal Framework
- Critical Issues
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