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Not the Same, But Not Too Different: Demonstrating ‘Biosimilarity’ for Biosimilars with Comparative PK and Immunogenicity Assays

As per the Food and Drug Administration (FDA) guidance Quality Considerations in Demonstrating Biosimilarity to a Reference Product, a biosimilar is defined as “a biological product that is highly similar to a reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”

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