FDA Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products

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Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products[附网盘链接]是Food And Drug Administration于当前发布的FDA标准，适用于United States。

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Draft — Not for Implementation 1 Clinical Immunogenicity Considerations for Biosimilar 2 and Interchangeable Insulin Products 3 1

4 Guidance for Industry 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 9 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 10 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 11 for this guidance as listed on the title page. 12 13 14 I. INTRODUCTION 15 16 The purpose of this guidance is to provide recommendations to applicants regarding whether and 17 when comparative clinical immunogenicity studies may be needed to support licensure of 18 proposed biosimilar and interchangeable recombinant human insulins, recombinant human 19 insulin mix products, and recombinant insulin analog products that are intended for the treatment 20 of patients with Type 1 or Type 2 diabetes mellitus (collectively described as “insulin products”). 21 The recommendations in this guidance are applicable only to proposed biosimilar and 22 interchangeable insulin products seeking licensure under section 351(k) of the Public Health 23 Service Act (PHS Act) in biologics license applications (BLAs). 24 25 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 26 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 27 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 28 the word should in Agency guidances means that something is suggested or recommended, but 29 not required. 30 31 II. BACKGROUND 32 33 A. The Pathway for Biosimilar and Interchangeable Insulin Products 34 35 Section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) 36 requires that on March 23, 2020, an approved application for a biological product under section 37 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355) will be deemed 38 to be a license for the biological product under section 351 of the PHS Act (42 U.S.C. 262). 39 Although the majority of therapeutic biological products have been licensed under section 351 of 1

This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA or the Agency). We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/drugs/guidance-

compliance-regulatory-information/guidances-drugs.

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