FDA Guidance for Industry: Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products

Titel:
FDA Guidance for Industry: Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products
Herkunft/Verlag:

FDA

Inhalt:
The purpose of this 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 (collectively described as “insulin products”)

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