Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products

On 25 November 2019 the FDA announced the availability of the draft guidance for comments by 27 January 2020.

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).

Read more online
Copyright Widler & Schiemann AG 2015. All Rights Reserved. /