Comment on "The End of Phase 3 Clinical Trials in Biosimilars Development?"
- PMID: 30117118
- PMCID: PMC6182457
- DOI: 10.1007/s40259-018-0297-y
Comment on "The End of Phase 3 Clinical Trials in Biosimilars Development?"
Conflict of interest statement
C. J. Webster consulted for Sandoz US Inc. for a single mock FDA Advisory Committee for a single biosimilar product during 2017. G. R. Woollett has no conflicts of interest.
Comment in
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Author's Reply to Webster and Woollett: "The End of Phase 3 Clinical Trials in Biosimilars Development?".BioDrugs. 2018 Oct;32(5):523. doi: 10.1007/s40259-018-0298-x. BioDrugs. 2018. PMID: 30117117 No abstract available.
Comment on
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The End of Phase 3 Clinical Trials in Biosimilars Development?BioDrugs. 2018 Aug;32(4):319-324. doi: 10.1007/s40259-018-0287-0. BioDrugs. 2018. PMID: 29943088
References
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- Biopharmaceutical industry-sponsored clinical trials: impact on state economies. Pharmaceutical Research and Manufacturers of America (PhRMA); 2015. http://phrma-docs.phrma.org/sites/default/files/pdf/biopharmaceutical-in.... Cited cost has been increased by 5% to account for real increase since publication of the report. Accessed 1 Aug 2018.
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- Sertkaya A, Birkenbach A, Berlind A, Eyraud J; Eastern Research Group, Inc. Examination of clinical trial costs and barriers for drug development. https://aspe.hhs.gov/report/examination-clinical-trial-costs-and-barrier.... Accessed 1 Aug 2018.
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- ICH E6 guideline for good clinical practice: a trial should be initiated and continued only if the anticipated benefits justify the risks. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Eff.... Accessed 1 Aug 2018.
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