Posted by Michael Wonder on 21 May 2019
FDA replaces withdrawn biosimilar guidance with new one on quality-related considerations
21 May 2019 - A week after finalizing guidance on developing interchangeable biosimilars, the US FDA has drafted guidance for biosimilar developers on the use of comparative analytical studies that can be used to assess whether a proposed product is biosimilar to a reference product.
The 28-page draft guidance revises a final guidance from 2015 on quality considerations for demonstrating biosimilarity and serves as a replacement for a 2017 draft guidance on statistical approaches to evaluating biosimilarity that was withdrawn last year after industry questions.
In addition to the focus on comparative analytical studies, the new draft also describes considerations and recommendations for sponsors on the scientific and technical information for the chemistry, manufacturing and controls portion of a biosimilar marketing application
