The FDA guidance for biosimilarity states: ‘The rationale for the analytical similarity assessment should be clearly described with consideration for the known quality attributes and performance characteristics of the specific reference product. Physicochemical and functional characterization studies should be sufficient to establish relevant quality attributes including those that define a product’s identity, quantity, safety, purity, and potency.’  Selected examples are presented that utilize the critical quality attribute framework to understand the relevant similarities and differences between the proposed biosimilar and the reference product, including process related impurities.

Using critical quality attributes in the development of biosimilars

251st National Meeting (2016)

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