FDA Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

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Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product[附网盘链接]由Food&Drug Administration于之前发布，适用于United States。

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Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug 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 requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance is intended to assist sponsors with the design and use of clinical pharmacology 2

studies to support a decision that a proposed therapeutic biological product is biosimilar to its reference product. This guidance pertains to those products—such as therapeutic biological products—for which pharmacokinetic (PK) and pharmacodynamic (PD) data are needed to support a demonstration of biosimilarity. Specifically, the guidance discusses some of the overarching concepts related to clinical pharmacology testing for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing clinical trials. This guidance is one in a series that FDA is developing to implement the Biologics Price 3

Competition and Innovation Act of 2009 (BPCI Act). This guidance is intended to assist sponsors in designing clinical pharmacology studies that can support an application submitted under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)) (a 351(k) 4

application) as part of a stepwise approach to support a demonstration of biosimilarity. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of 1

This 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. 2

Terms that appear in bold type are defined in the “Definitions” section at the end of this guidance. 3

Sections 7001 through 7003 of the Patient Protection and Affordable Care Act (Affordable Care Act), Public Law 111-148. 4

See FDA’s guidance for industry Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance Web page at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

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