Technical / White Paper
Functional Comparability of a Biosimilar
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.
Download this paper to learn about an alternative assay which provides time and cost savings during the functional characterization stage of development.