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Think of it like this: if your research protocol calls for a 250 microgram (mcg) dose, but your reconstitution math is off by 20%, you're not actually administering 250mcg

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10.1002/art.20604

Biosimilar Interchangeability: The Designation That Changes Pharmacy-Level Competition A biosimilar that receives an interchangeability designation from the FDA has cleared a higher evidentiary bar than standard biosimilarity, demonstrating that it can be expected to produce the same clinical result as the reference product in any given patient and that switching between the two carries no additional safety or efficacy risk