As the open question around interchangeable biosimilars in the US continues to drive the discussion on what the US Food and Drug Administration (FDA) will require for such a designation, some experts ...
The U.S. Food and Drug Administration (FDA) recently issued new revised draft guidance on “Labeling for Biosimilar and Interchangeable Biosimilar Products,” which most notably dispenses with any ...
Interchangeability impacts payer incentives, provider perceptions, and biosimilar adoption rates, with formulary status and complexity as barriers. Regulatory and legislative solutions are needed to ...
Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US. In 2009, Congress created a regulatory pathway for ...
A top biologics official with the US Food and Drug Administration (FDA) explained the agency’s rationale in proposing to eliminate interchangeability designations in prescriber labeling for ...
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