FDA Withdraws Draft Guidance on Statistical Approaches to Evaluate Analytical Similarity

Yesterday, the FDA announced that it was withdrawing a draft guidance document, “Statistical Approaches to Evaluate Analytical Similarity,” after consideration of public comments.

The draft guidance, released in September 2017, was intended to provide advice to biosimilar developers in regard to how the FDA evaluates analytical similarity between a proposed biosimilar and a reference product.

The FDA received comments on the draft guidance that addressed a variety of issues that could impact the cost and efficiency of biosimilar development. Comments addressed topics including the number of reference product lots the draft guidance would recommend that developers sample to evaluate similarity and the statistical methods for the evaluation. By better addressing the concerns raised, the FDA believes it will promote a more efficient pathway for the development of biosimilar products.

“We’re taking a fresh look at our draft recommendations for evaluating analytical studies in order to ensure our guidance takes into consideration the most current and relevant science. We’ll continue to work directly with biosimilar developers on their programs as we develop new draft guidance in this area,” said FDA Commissioner Scott Gottlieb, MD, in a statement.

The agency noted that it will issue future draft guidance that will reflect state-of-the-art techniques in the evaluation of analytical data to assist the biosimilar developer in demonstrating the similarity between a proposed biosimilar and its reference product.

“The goal is for future draft guidance to address potential challenges faced by biosimilar sponsors in designing studies that are intended to demonstrate that a proposed biosimilar product is highly similar to a reference product, including consideration of appropriate methods to analyze analytical data to account for potential lot-to-lot variability of the reference product,” read the announcement.

In addition, the FDA will also work to provide some flexibility for sponsors in order to incentivize the efficient development of biosimilars without compromising scientific standards.

“By supporting the more efficient development of biosimilars over the long term and helping reduce barriers to bringing these products to market, we can help ensure patients get access to affordable, safe, and effective treatment options,” said Gottlieb.