Scientific factors for assessing biosimilarity and drug interchangeability of follow-on biologics

References

• Schellekens H. How similar do ‘biosimilar’ need to be? Nat Biotechnol. 2004;22:1357–1359.
   PubMed Web of Science ®Google Scholar
• Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol. 2004;22:1383–1391.
   PubMed Web of Science ®Google Scholar
• Crommelin D, Bermejo T, Bissig M, et al. Biosimilars, generic versions of the first generation of therapeutic proteins: do they exist? Contrib Nephrol. 2005;149:287–294.
   PubMed Web of Science ®Google Scholar
• Roger SD, Mikhail A. Biosimilars: opportunity or cause for concern? J Pharm Sci. 2007;10:405–410.
   Web of Science ®Google Scholar
• Kozlowski S. FDA policy on follow on biologics. Presented at Biosimilars 2007, George Washington University, Washington DC, USA; 2007.
   Google Scholar
• Guidance on Statistical Approaches to Establishing Bioequivalence. Rockville, Maryland, USA: Center for Drug Evaluation and Research, the US Food and Drug Administration (FDA); 2001.
   Google Scholar
• Chow SC, Shao J, Wang H. Individual bioequivalence testing under 1 × 3 crossover designs. Stat Med. 2002;21:629–648.
   PubMed Web of Science ®Google Scholar
• Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987;15:657–680.
   PubMedGoogle Scholar
• Chow SC, Liu JP. Design and Analysis of.Bioavailability and Bioequivalence Studies. 3rd ed. New York: New York Chapman Hall/CRC Press, Taylor and Francis; 2008.
   Google Scholar
• Webber KO. Biosimilars: Are we there yet? Presented at Biosimilars 2007, George Washington University, Washington DC, USA; 2007.
   Google Scholar
• EMEA, Draft guideline on similar biological medicinal products containing monoclonal antibodies. EMA/CHMP/BMWP/403543/2010. London, United Kingdom: The European Medicines Agency Evaluation of Medicines for Human Use; 2010.
   Google Scholar
• EMEA, Note for Guidance on Comparability of Medicinal Products Containing Biotechnology-derived Proteins as Drug Substance – Non Clinical and Clinical Issues. EMEA/CHMP/3097/02. London, United Kingdom: The European Medicines Agency Evaluation of Medicines for Human Use; 2003.
   Google Scholar
• EMEA, Guideline on Comparability of Medicinal Products Containing Biotechnology- derived Proteins as Drug Substance – Quality Issues. London, EMEA/CHMP/ BWP/3207/00/Rev 1. United Kingdom: The European Medicines Agency Evaluation of Medicines for Human Use; 2003.
   Google Scholar
• EMEA, Guideline on Similar Biological Medicinal Products. EMEA/ CHMP/437/04. London, United Kingdom: The European Medicines Agency Evaluation of Medicines for Human Use; 2005.
   Google Scholar
• EMEA, Draft Guideline on Similar Biological Medicinal Products Containing Biotechnology- derived Proteins as Drug Substance: Quality Issues. EMEA/CHMP/49348/05. London, United Kingdom: The European Medicines Agency Evaluation of Medicines for Human Use; 2005.
   Google Scholar
• 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. EMEA/ CHMP/94526/05. London, United Kingdom: The European Medicines Agency Evaluation of Medicines for Human Use; 2005.
   Google Scholar
• 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. EMEA/CHMP/31329/05. London, United Kingdom: The European Medicines Agency Evaluation of Medicines for Human Use; 2005.
   Google Scholar
• 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. EMEA/CHMP/94528/05. London, United Kingdom: The European Medicines Agency Evaluation of Medicines for Human Use; 2005.
   Google Scholar
• 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. EMEA/ CHMP/32775/05. London, United Kingdom: The European Medicines Agency Evaluation of Medicines for Human Use; 2005.
   Google Scholar
• EMEA, Guideline on the Clinical Investigating of the Pharmacokinetics of Therapeutic proteins. EMEA/CHMP/89249/04. London, United Kingdom: The European Medicines Agency Evaluation of Medicines for Human Use; 2005.
   Google Scholar
• Woodcock J. The FDA’s assessment of follow-on protein products: A historical perspective. Nat Rev Drug Discov. 2007;6:437–442.
   PubMed Web of Science ®Google Scholar
• ICH Q5C Guideline on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products. Rockville, Maryland, USA: Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, the US Food and Drug Administration; 1996.
   Google Scholar
• ICH Q6B Guideline on Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Rockville, Maryland, USA: Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, the US Food and Drug Administration; 1999.
   Google Scholar
• Q5E Guideline on Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. Rockville, Maryland, USA: Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, the US Food and Drug Administration; 2005.
   Google Scholar
• Chow SC, Liu JP. Statistical assessment of biosimilar products. J Biopharm Stat. 2010;20:10–30.
   PubMed Web of Science ®Google Scholar
• EMEA, Note for Guidance on the Investigation of Bioavailability and Bioequivalence. EMEA/EWP/QWP/1401/98. London, United Kingdom: The European Medicines Agency Evaluation of Medicines for Human Use; 2001.
   Google Scholar
• World Health Organization Draft Revision on Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability. WHO: Geneva, Switzerland; 2005.
   Google Scholar
• Schall R, Luus HG. On population and individual bioequivalence. Stat Med. 1993;12:1109–1124.
   PubMed Web of Science ®Google Scholar
• Chow SC, Hsieh TC, Chi E, Yang J. A comparison of moment-based and probability-based criteria for assessment of follow-on biologics. J Biopharm Stat. 2010;20:31–45.
   PubMed Web of Science ®Google Scholar
• Hsieh TC, Chow SC, Liu JP, Hsiao CF, Chi E. Statistical test for evaluation of biosimilarity of follow-on biologics. J Biopharm Stat. 2010;20:75–89.
   PubMed Web of Science ®Google Scholar
• Chen ML, Patnaik R, Hauck WW, Schuirmann DF, Hyslop T, Williams R. An individual bioequivalence criterion – regulatory considerations. Stat Med. 2000;19:2821–2842.
   PubMed Web of Science ®Google Scholar
• Patnaik RM, Lesko LJ, Chen ML, Williams RL. Individual bioequivalence – new concepts in the assessment of bioequivalence metrics. Clin Pharmacokinet 1997;33:1–6.
   PubMed Web of Science ®Google Scholar
• Endrenyi L, Taback N, Tothfalusi L. Properties of the estimated variance component for subject-by-formulation interaction in studies of individual bioequivalence. Stat Med. 2000;19:2867–2878.
   PubMed Web of Science ®Google Scholar
• Chow SC, Endrenyi L, Lachenbruch PA. Assessing biosimilarity of follow-on biologics. Scientific Statistical Advisory Board, Amgen, Inc. Thousand Oaks, California. Unpublished white paper; 2010.
   Google Scholar
• Shao J, Chow SC. Reproducibility probability in clinical trials. Stat Med. 2002;21:7727–1742.
   Web of Science ®Google Scholar