Statistical assessment of biosimilarity based on relative distance between follow-on biologics

Statistics in Medicine

Volumn 32, Issue 3, 2013, Pages 382-392

  Kang, Seung Ho ^a   Chow, Shein Chung ^b  

^a Yonsei University   (South Korea)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Biosimilar; Linearization method; Parallel design; Ratio estimator; Similarity

Indexed keywords

BIOLOGICAL PRODUCT; BIOSIMILAR AGENT;

ARTICLE; BIOSIMILARITY; COMPARATIVE STUDY; LINEAR SYSTEM; PARALLEL DESIGN; PHARMACEUTICS; RELATIVE DISTANCE; STATISTICAL ANALYSIS; STATISTICAL PARAMETERS;

ALGORITHMS; BIOSIMILAR PHARMACEUTICALS; DRUG EVALUATION;

EID: 84872403675     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.5582     Document Type: Article

References (20)

1. Chow SC, Endrenyi L, Lachenbruch PA, Yang LY, Chi E. Scientific factors for assessing biosimilarity and drug interchangeability of follow-on biologics. Biosimilars 2011; 1:13-26.
2. EMEA. Note for Guidance on the Investigation of Bioavailability and Bioequivalence. The European Medicines Agency Evaluation of Medicines for Human Use, 2001. EMEA/EWP/QWP/1401/98, London, United Kingdom.
3. EMEA. Note for Guidance on Comparability of Medicinal Products Containing Biotechnology-derived Proteins as Drug Substance - Non Clinical and Clinical Issues. The European Medicines Agency Evaluation of Medicines for Human Use, 2003a. EMEA/CHMP/3097/02, London, United Kingdom.
4. EMEA. Rev. 1 Guideline on Comparability of Medicinal Products Containing Biotechnology-derived Proteins as Drug Substance - Quality Issues. The European Medicines Agency Evaluation of Medicines for Human Use, 2003b. EMEA/CHMP/BWP/3207/00/Rev 1, London, United Kingdom.
5. EMEA. Guideline on Similar Biological Medicinal Products. The European Medicines Agency Evaluation of Medicines for Human Use, 2005a. EMEA/CHMP/437/04, London, United Kingdom.
6. EMEA. Draft Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Drug Substance: Quality Issues. The European Medicines Agency Evaluation of Medicines for Human Use, 2005b. EMEA/CHMP/49348/05, London, United Kingdom.
7. EMEA. Draft Annex Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Drug Substance - Non Clinical and Clinical Issues - Guidance on Biosimilar Medicinal Products containing Recombinant Erythropoietins. The European Medicines Agency Evaluation of Medicines for Human Use, 2005c. EMEA/CHMP/94526/05, London, United Kingdom.
8. EMEA. Draft Annex Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Drug Substance - Non Clinical and Clinical Issues - Guidance on Biosimilar Medicinal Products containing Recombinant Granulocyte-Colony Stimulating Factor. The European Medicines Agency Evaluation of Medicines for Human Use, 2005d. EMEA/CHMP/31329/05, London, United Kingdom.
9. EMEA. Draft Annex Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Drug Substance - Non Clinical and Clinical Issues - Guidance on Biosimilar Medicinal Products containing Somatropin. The European Medicines Agency Evaluation of Medicines for Human Use, 2005e. EMEA/CHMP/94528/05, London, United Kingdom.
10. EMEA. Draft Annex Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Drug Substance - Non Clinical and Clinical Issues - Guidance on Biosimilar Medicinal Products containing Recombinant Human Insulin. The European Medicines Agency Evaluation of Medicines for Human Use, 2005f. EMEA/CHMP/32775/05, London, United Kingdom.
11. EMEA. Guideline on the Clinical Investigating of the Pharmacokinetics of Therapeutic proteins. The European Medicines Agency Evaluation of Medicines for Human Use, 2005g. EMEA/CHMP/89249/04, London, United Kingdom.
12. Chow SC. On scientific factors of biosimilarity and interchangeability. Presented at the FDA Public Hearing on Approval Pathway for Biosimilar and Interchangeable Biological Products, 2010. Silver Spring, Maryland, November 2-3, 2010.
13. FDA. Guidance for Industry - Dissolution Testing of Immediate Release Solid Oral Dosage Forms. the U.S. Food and Drug Administration, Rockville, Maryland, 1997.
14. FDA. Guidance on Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Consideration. Center for Drug Evaluation and Research, the U.S. Food and Drug Administration, Rockville, Maryland, 2003.
15. Chow SC, Liu JP. Design and Analysis of Bioavailability and Bioequivalence Studies, (3rd end). Chapman and Hall/CRC Press, Taylor & Francis: New York, 2008.
16. Fieller EC. The biological standardization of insulin. Supplement to the Journal of the Royal Statistical Society 1940; 7:1-64.
17. Fieller EC. A fundamental formula in the statistics of biological assay, and some applications. Quarterly Journal of Pharmacy and Pharmacology 1944; 17:117-123.
18. Hyslop T, Hsuan F, Holder DJ. A small sample confidence interval approach to assess individual bioequivalence. Statistics in Medicine 2000; 19:2885-2897.
19. Pigeot I, Schafer J, Rohmel J, Hauschke D. Assessing non-inferiority of a new treatment in a three-arm clinical trial including a placebo. Statistics in Medicine 2003; 22:883-899.
20. Howe WG. Approximate confidence limits on the mean of X+Y where X and Y are two tabled independent random variables. Journal of the American Statistical Association 1974; 69:789-794.