FDA Biosimilarity and Interchangeability Additional Draft Q&As on Biosimilar Development and the BPCI Act Draft

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Biosimilarity and Interchangeability Additional Draft Q&As on Biosimilar Development and the BPCI Act Draft[附网盘链接]是于之前发布的FDA标准，适用于U.S。

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Draft — Not for Implementation 1 Biosimilarity and Interchangeability: Additional Draft Q&As on 2 Biosimilar Development and the BPCI Act 1

3 Guidance for Industry 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 INTRODUCTION 15 16 This draft guidance document provides answers to common questions from prospective 17 applicants and other interested parties regarding the Biologics Price Competition and Innovation 18 Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform 19 prospective applicants and facilitate the development of proposed biosimilar products and 2

20 proposed interchangeable products, as well as describe FDA’s interpretation of certain statutory 21 requirements added by the BPCI Act. 22 23 The BPCI Act created an abbreviated licensure pathway in section 351(k) of the Public Health 24 Service Act (PHS Act) for biological products shown to be biosimilar to, or interchangeable 25 with, an FDA-licensed biological reference product (see sections 7001 through 7003 of the 26 Patient Protection and Affordable Care Act (Pub. L. 111–148) (ACA)). FDA believes that 27 guidance for industry that provides answers to commonly asked questions regarding FDA’s 28 interpretation of the BPCI Act will enhance transparency and facilitate the development and 29 approval of biosimilar and interchangeable products. In addition, these Q&As respond to 30 questions the Agency has received from applicants regarding the submission of biologics license 31 applications (BLAs) for biosimilar and interchangeable products. FDA may provide additional 32 Q&As through draft guidance as appropriate. 33 1

This draft guidance has been prepared by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug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. 2

In this draft guidance, the following terms are used to describe biological products licensed under section 351(k) of the Public Health Service Act (PHS Act): (1) biosimilar or biosimilar product refers to a product that FDA has determined to be biosimilar to the reference product (see sections 351(i)(2) and 351(k)(2) of the PHS Act) and (2) interchangeable biosimilar or interchangeable product refers to a biosimilar product that FDA has also determined to be interchangeable with the reference product (see sections 351(i)(3) and 351(k)(4) of the PHS Act). The terms proposed biosimilar product and proposed interchangeable product are used to describe a product that is under development or is the subject of a pending 351(k) BLA. Biosimilarity, interchangeability, and related issues are discussed in more detail in the BACKGROUND section of this draft guidance.

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