Assessing biosimilarity and interchangeability of biosimilar products

Statistics in Medicine

Volumn 32, Issue 3, 2013, Pages 361-363

  Chow, Shein Chung ^a  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; GENERIC DRUG;

BIOEQUIVALENCE; BIOSIMILARITY; DRUG APPROVAL; DRUG COST; DRUG INTERCHANGEABILITY; DRUG MARKETING; EDITORIAL; FOOD AND DRUG ADMINISTRATION; PHARMACEUTICS; SCORING SYSTEM; STATISTICAL ANALYSIS;

BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; GOVERNMENT REGULATION; PATENTS AS TOPIC; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84872419787     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.5577     Document Type: Editorial

References (8)

1. Chow SC, Liu JP.Design and Analysis of Bioavailability and Bioequivalence Studies-Revised and Expanded, Third edn. Taylor & Francis: New York, New York, 2008.
2. Simoens S, Verbeken G, Huys I.Market access of biosimilars: not only a cost issue. Oncologie 2011; 13(5):218-221.
3. GaBI Online. Generics and Biosimilars Initiative. Generics grab 80% share of US market and fill 78% of prescriptions [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Mar 23], 2012a. Available from: www.gabionline.net/Reports/Generics-grab-80-share-of-US-marketand-fill-78-of-prescriptions.
4. GaBI Online. Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Mar 23], 2012b. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe.
5. Chow SC, Liu JP.Statistical assessment of biosimilar products. Journal of Biopharmaceutical Statistics 2010; 20:10-30.
6. Chow SC, Hsieh E, Chi E, Yang J.A comparison of moment-based and probability-based criteria for assessment of follow-on biologics. Journal of Biopharmaceutical Statistics 2010; 20:31-45.
7. Chow SC.Quantitative evaluation of bioequivalence/biosimilarity. Journal of Bioequivalence and Bioavailability 2011; Suppl. 1-002:1-8.http://dx.doi.org/10.4172/jbbs1-002.
8. 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.