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# Draft Guide on Biosimilar Clinical Immunogenicity
- URL: https://www.fdaweb.com/draft-guide-on-biosimilar-clinical-immunogenicity/
- Published: 2019-11-27T12:00:00.000Z
- Updated: 2026-09-14T15:54:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145603

*Federal Register* notice: FDA has made available a draft guidance entitled “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.” The document provides 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 Type2 diabetes mellitus. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-25919.pdf?ref=fdaweb.com).