FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity

The Food and Drug Administration (FDA or Agency) is withdrawing the draft guidance for industry entitled “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017.  The draft guidance, if finalized as written, was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product.

The agency intends to issue future draft guidance that will reflect state-of-the-art techniques in the evaluation of analytical data to support a demonstration that a proposed biosimilar product is highly similar to a reference product.
The FDA continues to encourage sponsors of proposed biosimilar products to discuss product development plans with the agency, including the evaluation of analytical data intended to support a demonstration that the proposed biosimilar product is highly similar to a reference product.  The FDA will continue to provide development-stage advice to sponsors of proposed biosimilar products or proposed interchangeable products through several types of formal meetings, which are described in more detail in FDA’s guidance for industry, Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.
More information about this and other FDA guidance documents related to biosimilar products and interchangeable products, as well as contact information for FDA, is available at http://www.fda.gov/biosimilars.
The FDA will communicate publicly when new draft guidance is issued in relation to the evaluation of analytical data between a proposed biosimilar product and a reference product.