ABSTRACT
Conducting appropriate statistical analyses in the evaluation of analytical similarity can provide a high degree of confidence in the results and reduce the potential for bias. Sponsors should develop an analytical similarity assessment plan that includes their proposed statistical approach to evaluation and then should discuss this approach with the Food and Drug Administration (FDA) as early in the development program as feasible. The FDA recommends that the analytical similarity assessment plan be carefully designed to identify and address all factors that could impact the determination about whether the proposed biosimilar is highly similar to the reference product. The FDA recommends that biosimilar sponsors develop a risk assessment tool to evaluate and rank the reference product quality attributes in terms of potential clinical impact. The analytical similarity testing forms the most critical stage of determining whether a biosimilar candidate is indeed a viable candidate.
