HomeDealsNegotiationsPolicyPipelineMoneyPeopleDataThe WeekPharmTech 100Deal TrackerResearch
Pipeline

How does biosimilar interchangeability differ from FDA approval?

FDA approval as a biosimilar allows prescribing and formulary placement, but state pharmacy laws govern automatic substitution. Interchangeable designation requires additional switching studies demonstrating no clinically meaningful differences when alternating between biosimilar and reference product. Only interchangeable biosimilars can be substituted at the pharmacy without prescriber approval.