FDA Development of Therapeutic Protein Biosimilars Comparative Analytical Assessment and Other Quality-Related Considerations
标准简介
Development of Therapeutic Protein Biosimilars Comparative Analytical Assessment and Other Quality-Related Considerations[附网盘链接]由FDA于之前发布，适用于U.S。标准截图
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标准文档说明
标准文档类型为Development of Therapeutic Protein Biosimilars Comparative Analytical Assessment and Other Quality-Related Considerations[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Draft — Not for Implementation 1 Development of Therapeutic Protein Biosimilars: Comparative 2 Analytical Assessment anuality-Related Considerations d Other Q 3 1 4 Guidance for Industry 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency on this topic.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 ) person and is nfor any ot 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 15 16 I. INTRODUCTION 17 18 This guidance describes the Agenign and evaluation of cy’s recommendations on the des
19 comparative analytical studiesion that a proposed therapeutic intended to support a demonstrat
20 protein product is biosimo a reference product licensed under section 351(a) of the Public ilar t
21 Health Service Act (PHS Act). Additionally, this guidance is intended to provide 22 recommendations to sponsors on the scientific and technical information for the chemistry, 23 manufacturing, and controls (CMC) portion of a mation for a proposed product arketing applic
24 submitted under section 351(k) of the PHS Act. 25 26 The Biologics Price Competition I Act) amand Innovationends the PHS Act Act of 2009 (BPC
27 and other statutes to create an abbreviated licensure pathway in section 351(k) of the PHS Act 28 for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed 29 reference product (see sections 7001 through 7003 of the Patient Protection and Affordable Care 30 Act (ACA) (Public Law 111-148). Although the 351(k) pathway applies generally to biological 31 products, this guidance f on therapeutic protein productsocuses and provides an overview of 32 recommendations for the comther parative analytical assessmimportant scientific ent and o
33 considerations to support a demonstration of biosimeen a proposed therapeutic ilarity betw
1
This guidrdance aft has been by p trepahe Cred entvaluation and Researcer for DrugER E) and the Ch (CDenter for Biologics Evalu (ation and ResCBER) at the Fodearchmodin andistratio Drug An. 1
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