Technical / White Paper

Functional Comparability of a Biosimilar

Published

Format: PDF file | Document type: Technical / White Paper

SGS-LSS

Regulatory authorities require head-to-head comparison at multiple levels to demonstrate that a proposed biosimilar is “similar or highly similar” to the reference product. Structural and functional characterization is essential to demonstrating biosimilarity prior to further clinical development. Decisions based on factors observed during initial analytical screening could result in a shortened clinical development process.

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