Guidance for Industry
Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
工业指南
质量考虑证实与参考蛋白产品生物相似性
DRAFT GUIDANCE
This guidance document is being distributed for comment purpos only.
此指南发布征求意见的目的只有
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments
should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
关于此草案的意见和建议应于联邦公报上宣布的指南草案的征求意见稿有效性的通知60天内提交。
For questions regarding this draft document contact (CDER) Sandra Benton at 301-796-2500.
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Rearch (CDER) Center for Biologics Evaluation and Rearch (CBER)
February 2012
Biosimilarity
Guidance for Industry
Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 Center for Drug Evaluation and Rearch Food and Drug Administration 10903 New Hampshire Ave., Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 druginfo@v
v/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
and/or
猴简笔画Office of Communication, Outreach, and Development, HFM-40 Center for Biologics Evaluation and Rearch Food and Drug Administration 1401 Rockville Pike, Rockville, MD 20852-1448 (Tel) 800-835-4709 or 301-827-1800
v/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Rearch (CDER) Center for Biologics Evaluation and Rearch (CBER)
February 2012 Biosimilarity Contains Nonbinding Recommendations
三只小兔
Draft — Not for Implementation
TABLE OF CONTENTS
红眼病怎么传染
I. 1
II. BACKGROUND ............................................................................................................... 2
III. SCOPE ............................................................................................................................... 4
IV. DEFINITIONS .................................................................................................................. 5
警察和赞美诗V. GENERAL PRINCIPLES ............................................................................................... 6
猛男腹肌VI. FACTORS FOR CONSIDERATION IN ASSESSING WHETHER PRODUCTS ARE HIGHLY SIMILAR ............................................................................................................ 9
A. Expression System .........................................................................................................................9
B. 10
白芍的作用与功效C. Asssment of 10
D. Functional Activities ....................................................................................................................11
E. Receptor Binding and .12
F. Impurities .....................................................................................................................................12
小班阅读区教案G. Reference Product and 13
H. Finished Drug Product ................................................................................................................14
I. 15
VII. CONCLUSION ............................................................................................................... 15
