FDA发布支持生物类似药相似性证明的临床药理学数据定稿指南（FDA-2014-D-0234）
Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
FDA（CDER与CBER）发布定稿指南，说明评估拟议生物类似药与参照产品相似性所需临床药理学数据，文件编号FDA-2014-D-0234。该指南定稿了2014年5月发布的同名草案，属于FDA为实施2009年《生物制品价格竞争与创新法案》（BPCI Act）制定的系列指南之一。FDA表示可就该指南随时提交评论。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2014-D-0234
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.” This guidance is to assist the pharmaceutical industry and other investigators engaged in biosimilar product development in determining the clinical pharmacology data necessary for evaluation of a proposed biosimilar product. This guidance finalizes the draft guidance with the same name issued in May 2014. This guidance is one in a series of guidances that FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2014-D-0234.
来源：FDA Pharmaceutical Quality Documents · fda.gov