Comments on the FDA draft guidance on biosimilar products

Statistics in Medicine

Volumn 32, Issue 3, 2013, Pages 364-369

  Chow, Shein Chung ^a   Endrenyi, Laszlo ^b   Lachenbruch, Peter A ^c  

^a DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF TORONTO   (Canada)

^c OREGON STATE UNIVERSITY   (United States)

Author keywords

Biosimilarity; FDA guidance; Scientific considerations; Step by step approach; Totality of the evidence

Indexed keywords

BIOSIMILAR AGENT; GENERIC DRUG;

ARTICLE; BIOEQUIVALENCE; BIOSIMILARITY; COMPARATIVE STUDY; DRUG APPROVAL; DRUG INTERCHANGEABILITY; DRUG MANUFACTURE; DRUG RESEARCH; FOOD AND DRUG ADMINISTRATION; LICENSING; PHARMACEUTICS; STATISTICAL ANALYSIS; STUDY DESIGN; UNITED STATES; VALIDATION PROCESS;

BIOSIMILAR PHARMACEUTICALS; DRUG APPROVAL; DRUG EVALUATION; GUIDELINES AS TOPIC; PHARMACOKINETICS; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84872416874     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.5572     Document Type: Article

References (8)

1. 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
2. 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.
3. Chow SC, Liu JP. Statistical assessment of biosimilar products. Journal of Biopharmaceutical Statistics 2010; 20:10-30.
4. USP/NF XXI. United States Pharmacopeia 24 and National Formulary 19, United States Pharmacopeial Convention, Inc., Rockville, Maryland, 2000.
5. 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.
6. Chow SC, Liu JP. Design and Analysis of Bioavailability and Bioequivalence Studies - Revised and Expanded, Third Edition. Taylor & Francis: New York, New York, 2008.
7. Hsieh TC, Chow SC, Liu JP, Hsiao CF. Statistical test for evaluation of biosimilarity in variability of follow-on biologics. Journal of Biopharmaceutical Statistics 2010; 20:75-89.
8. Kang SH, Chow SC, Tsong Y. Statistical assessment of biosimilarity based on relative distance between follow-on biologics. Statistics in Medicine 2012. To appear.