Issue Date: November 25, 2019
Issued by: Center for Drug Evaluation and Research
Topic(s): Biosimilars
Status: Draft
Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products
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”). The recommendations in this guidance are applicable only to proposed biosimilar and interchangeable insulin products seeking licensure under section 351(k) of the Public Health Service Act (PHS Act) in biologics license applications (BLAs).
Download the Guidance Document
Related Service(s): Immunogenicity Testing Services
