BioCentury
ARTICLE | Politics & Policy

FDA moves to waive immunogenicity studies for biosimilar insulin

November 26, 2019 6:52 PM UTC
Updated on Dec 7, 2019 at 3:43 AM UTC

FDA issued draft guidance on Tuesday that would streamline the approval process for certain biosimilar or interchangeable insulin products by eliminating the need for costly and time-consuming comparative clinical immunogenicity studies.

In the guidance, the agency stated that if a comparative analytical assessment demonstrates a proposed biosimilar or interchangeable insulin product is "highly similar" to its reference product, "there would be little or no residual uncertainty regarding immunogenicity." ...