Biosimilars vs. Interchangeable Biological Products: FDA Fact Check
XTalks
FEBRUARY 8, 2021
Crucially, biosimilars manufacturers must also demonstrate that their product’s safety and efficacy profile won’t go down if a patient switches back and forth between the biosimilar and the reference product during the course of treatment. Because most biologics are mixtures of variants, they really can’t be copied exactly.”.
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