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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

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Warnings Management of Acute Allergic Reactions Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer-BioNTech COVID-19 Vaccine

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