Streamlining Approval for Interchangeable Biosimilar Drugs to Lower Costs.
This Act aims to speed up the availability of lower-cost versions of expensive biologic drugs (biosimilars). It removes the requirement for manufacturers to conduct extra studies to prove a biosimilar is 'interchangeable' with the original drug. This change is expected to increase market competition and potentially lower prescription costs for patients by allowing easier substitution by pharmacists.
Key points
Biosimilar drugs will be automatically deemed 'interchangeable' with the reference product upon approval, removing a major regulatory hurdle.
This change facilitates easier substitution by pharmacists, increasing competition and potentially lowering the cost of complex treatments for consumers.
Existing market exclusivity periods for certain previously approved interchangeable products remain protected under transition rules.
Status:
Introduced
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