Biosimilar Red Tape Elimination Act

Key Points

• Would make most biosimilar medicines automatically interchangeable with the original biologic once approved, instead of needing a separate extra decision.
• Sets a switch-over date 60 days after the bill becomes law. Biosimilars approved before then become interchangeable on that date.
• Keeps existing “first interchangeable” exclusivity protections for certain older products, so some automatic switching could be delayed until that period ends.
• Requires the Health Department to update and revise its public guidance within 18 months so drug companies know what data to submit.
• Does not change the basic safety and effectiveness standard for biosimilars; it mainly changes how interchangeability is handled and documented.