FDA scraps biosimilars draft guidance

In an effort to reduce the cost and increase the efficiency of biosimilars development, FDA Thursday withdrew draft guidance on statistical approaches for evaluating analytical similarities between a proposed biosimilar and its reference product. The agency highlighted comments it has received regarding the number of reference product lots that it requires biosimilars manufacturers to sample, as well as the statistical methods used to evaluate samples.

FDA plans to issue new draft guidance that “will reflect state-of-the-art techniques in the evaluation of analytical data to support a demonstration that a proposed biosimilar product is highly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,” FDA Commissioner Scott Gottlieb said in a statement. The new draft guidance, he said, will take into consideration “appropriate methods to analyze analytical data to account for potential lot-to-lot variability of the reference product.”...