On June 21, 2018, the Food and Drug Administration (FDA) withdrew its draft guidance for industry entitled “Statistical Approaches to Evaluate Analytical Similarity,” originally issued in September 2017. The draft guidance concerned advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product. After consideration of public comments that addressed a range of issues potentially impacting the cost and efficiency of biosimilar development, the FDA decided to further consider the scientific and regulatory issues involved and withdrew the draft guidance.
The FDA stated that it intends to issue future draft guidance that will “reflect state-of-the art techniques in the evaluation of analytical data,” address “appropriate methods to analyze analytical data to account for potential lot-to-lot variability in the reference product,” and “focus on providing appropriate flexibility for sponsors. . . [to] spur the efficient development of biosimilars without compromising the agency’s rigorous scientific standards for evaluating marketing applications for biosimilars.”
Readers are encouraged to review the FDA’s withdrawal here.
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