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Abstract:
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Per the FDA Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products published in August 2014, the Agency recommends that sponsors should develop and implement sensitive immunoassays commensurate with the overall product development program. Some sponsors, however, do not develop the immunoassays by themselves rather rely on the immunoassays reported in the literature. As such, it is hard to judge how well the immunoassays will perform in the hands of a specific sponsor. When using a two-arm non-inferiority immunogenicity study, we assume that the immunoassay is as sensitive as reported. To alleviate the risk in making assumptions on the assay sensitivity (AS) is to include a placebo arm. With the three-arm study, we can demonstrate whether the active control (or reference product) performs similarly as reported in the literature and lessen the concern on assay validation. The current research is to design and evaluate three-arm non-inferiority (NI) immunogenicity studies for approval of biosimilar products when there is not enough information available on the sensitivity of immunoassays.
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