Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments-Reference-Cited by-同舟云学术

Systematic Verification of Bioanalytical Similarity Between a Biosimilar and a Reference Biotherapeutic: Committee Recommendations for the Development and Validation of a Single Ligand-Binding Assay to Support Pharmacokinetic Assessments

Published:2014-10-03 Issue:6 Volume:16 Page:1149-1158
ISSN:1550-7416
Container-title:The AAPS Journal
language:en
Short-container-title:AAPS J

Author:

Marini Joseph C.,Anderson Michael,Cai Xiao-Yan,Chappell John,Coffey Todd,Gouty Dominique,Kasinath Aparna,Koppenburg Vera,Oldfield Philip,Rebarchak Shannon,Bowsher Ronald R.

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Link

http://link.springer.com/content/pdf/10.1208/s12248-014-9669-5.pdf

Reference20 articles.

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2. U.S. Department of Health and Human Services. Food and Drug Administration. Docket No. FDA-2010-N-0477. Approval pathway for biosimilar and interchangeable biological Products. Public Hearing November 2010.

3. European Medicines Agency. CHMP/437/04. Guideline on similar biological medicinal products. October 2005.

4. European Medicines Agency. EMEA/CHMP/BMWP/42832/2005. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues. June 2006.

5. European Medicines Agency. EMEA/CHMP/BWP/49348/2005. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Quality issues. June 2006.

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