FDA Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry

标准简介

Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于United States。

标准截图

 

标准文档说明

标准文档类型为Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry[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

Considerations in Demonstrating Interchangeability

With a Reference Product

1

Guidance for Industry This guidance represents trrent thinking of the Food and Dhe curug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requires of the applicable statutes and regulations. ment

To discuss an alternative aoach, contact the FDA onsible for this ppr office respguidance as listed on the title page. I. INTRODUCTION This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplemsection 351(k) of the Public Heent under alth Service Act (PHS Act) (42 U.S.C. 262(k)). The Biologics Price Com Act of 2009 (BPCI Act) petition and Innovation

amends the PHS Act and other statlicensure pathway in section utes to create an abbreviated 2

351(k) of the PHS Act for biological products shown to be biosimilar to or interchangeable with 3

an FDA-licensed biological reference product (see sections 7001 through 7003 of the Patient Protection and Affordable Care Act (Affordable Care Act) (Public Law 111-148)). Although the 351(k) pathway applies generally to biological products, this guidance focuses on therapeutic protein products and gives an overview of imporconsiderations in demtant scientific onstrating interchangeability of a proposed therapeutic protein product (proposed interchangeable 4 biosimilar or proposed interchangeable product) with a reference product. 1

This guid ance has bee n prethpae red Ce n byter taluation and Reshe for OfDfruice og Evf Newearch Drugs in (CDER) i n cooperation with the C and Resenteearch (CBER) ar t thfor e FoBiolodogi andcs DEvalrug uation Administration. 2

Section 351(i)(2) of thbiosimilae PHS Ar obir osimilact drity teo mfinean t es hat “t he b iological product is highly similar to the r eference prcesod iucn clt notinwiicalthstlyan i dnacting mivie conor dimponentfferens” (highly similar provision) ando clin that “thically erences armeane bet ningfween the biological ul d priffereoduct and the reference product in term, purity, as of th nd potency e safetyuct” (no clof ithe n icalprodly meani ngful differences provision). 3

Section 351(iref)(erence pr4) defoducti tnes o mean “the single biologion cal(a) product licensed under subsecti

agai nst whi ch a biological on spruobmduitctt ied s eun vdealr suatuebd isecnt aion n a(kp).” plicati

4

In t his guidance, the fol lloowigi ngcal termprosd are usucts li ecensed to ded usndecrir sectbe bioion 351(k) of the PHS Act: (1) “biossiimmilar” oilar pr r “bodproduuctio” ct threferas tt FDA ho a as d etermined to be biosimilar to the reference prod uct (see thsece PHS Act) antions 3r51c(i)(hand2 (2) ga) “ineandbl 3te5e 1(kbi)(2) oof similar” or “interchangeable product” refers to a biosim iDA has determinelar produd toct th be inat tFerch angeable with the reference product ( see section PHS Act)s 3. 51(i)(3) and 351(k)(4) of the 1

网盘链接

百度网盘：https://pan.baidu.com/s/1Ij-ir_yP39ss2P2RdLV_4g
提取码：7tvv