FDA biosimilar guidance details statistical analysis plan

FDA released draft guidance outlining how companies developing biosimilar candidates should design statistical plans for demonstrating analytical biosimilarity to reference products.

As laid out in its final guidance for demonstrating biosimilarity issued in 2015, FDA recommends sponsors use a stepwise approach for biosimilar development, beginning with an analytical similarity assessment comparing the structural/physicochemical and functional attributes of the proposed biosimilar product to the reference product. Analytical data forms the foundation of the assessment, with the amount of clinical data required determined based on the degree of similarity established through analytics. ...