Biosimilar Red Tape Elimination Act

Key Provisions

• A biological product licensed as biosimilar would be automatically considered interchangeable with its original drug.
• Newly licensed biosimilar drugs would be deemed interchangeable right away, unless another biosimilar for the same original drug has an existing exclusivity period.
• Existing biosimilar drugs would become interchangeable 60 days after the bill becomes law, unless another biosimilar for the same original drug has an existing exclusivity period.
• Preserves existing "first interchangeable" exclusivity periods for certain biological products licensed before the bill becomes law.
• Requires the Food and Drug Administration (FDA) to update its guidance on biosimilar and interchangeable products within 18 months after the bill becomes law.