Drugmakers Weigh in on FDA’s Biosimilar Insulin Guidance
In comments to the FDA, drugmakers called on the agency to clarify in its draft guidance for biosimilar and interchangeable insulin products that the agency will still hold applicants to the current licensing standards.
In the guidance, the agency spelled out that, under certain circumstances, it would not look for a comparative clinical immunogenicity study from sponsors of certain biosimilar and interchangeable insulin products.
Amgen pressed the agency to clarify that in cases where comparative clinical immunogenicity studies are not needed, sponsors are still expected to address the criteria for licensure as a biosimilar or interchangeable product.
The final guidance should emphasize that the omission of comparative immunogenicity studies does not mean that there is a “lesser standard” for proving biosimilarity or interchangeability, Amgen said.