Group Comment Letter to FDA on Clinical Immunogenicity Considerations from Biosimilar and Interchangeable Insulin Products
Dear Commissioner Hahn,
The undersigned groups share the Food and Drug Administration’s (FDA) deep commitment to the development of a robust biosimilars market and appreciate the Agency’s work to develop an efficient approval pathway for biosimilars to bring savings and access to America’s patients. As such, we support the approach outlined in the “Clinical Immunogenicity Considerations from Biosimilar and Interchangeable Insulin Products” draft guidance. Specifically, we agree with the Agency’s assessment that if a manufacturer demonstrates its proposed biosimilar insulin is “highly similar” to its reference product, the Agency may waive the need for the manufacturer to conduct additional immunogenicity studies in order for the Agency to deem the product as interchangeable with its reference product.
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