federal_register: 2019-25919

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2019-25919 Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products." The purpose of this draft guidance is to provide recommendations to applicants regarding whether and when comparative clinical immunogenicity studies may be needed to support licensure of proposed biosimilar and interchangeable recombinant human insulins, recombinant human insulin mix products, and recombinant insulin analog products that are intended for the treatment of patients with Type 1 or Type 2 diabetes mellitus. 2019-11-29 2019 11 https://www.federalregister.gov/documents/2019/11/29/2019-25919/clinical-immunogenicity-considerations-for-biosimilar-and-interchangeable-insulin-products-draft https://www.govinfo.gov/content/pkg/FR-2019-11-29/pdf/2019-25919.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products." The purpose of this draft guidance...

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