Use of pharmacodynamic/response biomarkers for therapeutic biologics regulatory submissions
References
- 1. . Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective. Biomark. Med., 2(3), 305–311 (2008).
- 2. . Biomarkers in drug development and regulation: a paradigm for clinical implementation of personalized medicine. Biomark. Med., 5(6), 705–713 (2011).
- 3. . Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease. Nat. Rev. Drug Discov., 17(2), 79–80 (2018).
- 4. . Multiplex assay for multiomics advances in personalized-precision medicine. J. Immunoassay Immunochem., 40(1), 3–25 (2019).
- 5. FDA-NIH Biomarker Working Group. BEST (Biomarkers, EndpointS, and other Tools) Resource (2016). www.ncbi.nlm.nih.gov/pubmed/27010052
- 6. . Biomarker qualification: toward a multiple stakeholder framework for biomarker development, regulatory acceptance, and utilization. Clin. Pharmacol. Ther., 98(1), 34–46 (2015).
- 7. Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact. Nat. Rev. Drug Discov., 9(6), 435–445 (2010).
- 8. . Biomarker validation and testing. Mol. Oncol., 9(5), 960–966 (2015).
- 9. US FDA. FDA's guidance for industry: clinical pharmacology data to support a demonstration of biosimilarity to a reference product (2016). www.fda.gov/media/88622/download
- 10. . Learning versus confirming in clinical drug development. Clin. Pharmacol. Ther., 61(3), 275–291 (1997).
- 11. Preclinical pharmacokinetic/pharmacodynamic modeling and simulation in the pharmaceutical industry: an IQ consortium survey examining the current landscape. AAPS J., 17(2), 462–473 (2015).
- 12. . How well are we applying quantitative methods to reverse translation to inform early clinical development? Clin. Pharmacol. Ther., 103(2), 174–176 (2018).
- 13. US FDA. Table of surrogate endpoints that were the basis of drug approval or licensure (2019). www.fda.gov/drugs/development-resources/table-surrogate-endpoints-were-basis-drug-approval-or-licensure
- 14. US FDA. Listing of FDA's biosimilarity guidances (2019). www.fda.gov/vaccines-blood-biologics/general-biologics-guidances/biosimilars-guidances
- 15. PF-06881893 (Nivestym), a filgrastim biosimilar, versus US-licensed filgrastim reference product (US-Neupogen®): pharmacokinetics, pharmacodynamics, immunogenicity, and safety of single or multiple subcutaneous doses in healthy volunteers. BioDrugs, 33(2), 207–220 (2019).
- 16. A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim. J. Cancer Res. Clin. Oncol., 144(6), 1087–1095 (2018).
- 17. . Pharmacokinetic and pharmacodynamic equivalence of epoetin hospira and epogen after single subcutaneous doses to healthy male subjects. Clin. Ther., 38(8), 1778–1788 (2016).
- 18. . Pharmacodynamic and pharmacokinetic equivalences of epoetin hospira and Epogen® after multiple subcutaneous doses to healthy male subjects. Clin. Ther., 38(5), 1090–1101 (2016).
- 19. . Application of pharmacometric analysis in the design of clinical pharmacology studies for biosimilar development. AAPS J., 20(2), 40 (2018).
- 20. Role of modeling and simulation in the development of novel and biosimilar therapeutic proteins. J. Pharm. Sci., 108(1), 73–77 (2019).