Biosimilar Red Tape Elimination Act
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Summary
The Biosimilar Red Tape Elimination Act amends federal law to streamline the approval process for biosimilar biological products by eliminating the separate interchangeability determination requirement. Under the bill, biosimilar products licensed after a 60-day transition period would be automatically deemed interchangeable with their reference products upon licensure, subject to certain exclusivity protections for previously approved biosimilars. The bill also requires the FDA to update guidance documents within 18 months to reflect these changes.
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