FDA Simplifies Biosimilar Development with New Draft Guidance
The US Food and Drug Administration (FDA) has introduced new draft guidance to streamline and expedite the biosimilar development process.
The regulatory framework aims to reduce the reliance on "unnecessary clinical testing" during the approval process, eliminating the need for biosimilar manufacturers to conduct comparative efficacy studies.
The draft guidance is touted as a way to reduce the cost and time-associated burden of biosimilar development.
- The new guidance has received a mixed reaction from the industry.
- The FDA's goal is to cut the cost and time-associated burden of biosimilar development.
Author's summary: FDA simplifies biosimilar development process.
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