Comment on: "Safety of Marketed Cancer Supportive Care Biosimilars in the U.S.: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database"
- PMID: 33860919
- PMCID: PMC8084790
- DOI: 10.1007/s40259-021-00476-9
Comment on: "Safety of Marketed Cancer Supportive Care Biosimilars in the U.S.: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database"
Conflict of interest statement
J. Putzke, S. Haughie, K.H. Zou, and G.M. Ranganna are full-time employees of and declares stock holdings or stock options from Viatris.
Comment in
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Author's Reply to Joerg Putzke et al. Comment on: "Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database".BioDrugs. 2021 May;35(3):375-377. doi: 10.1007/s40259-021-00474-x. Epub 2021 Apr 16. BioDrugs. 2021. PMID: 33860920 No abstract available.
Comment on
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Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database.BioDrugs. 2021 Mar;35(2):239-254. doi: 10.1007/s40259-020-00466-3. Epub 2021 Jan 13. BioDrugs. 2021. PMID: 33439472
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Cited by
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Author's Reply to Joerg Putzke et al. Comment on: "Safety of Marketed Cancer Supportive Care Biosimilars in the US: A Disproportionality Analysis Using the Food and Drug Administration Adverse Event Reporting System (FAERS) Database".BioDrugs. 2021 May;35(3):375-377. doi: 10.1007/s40259-021-00474-x. Epub 2021 Apr 16. BioDrugs. 2021. PMID: 33860920 No abstract available.
References
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- FDA Adverse Event Reporting System (FAERS) Public Dashboard. FDA. 2020. https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-repor.... Accessed 4 Feb 2021.
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- Guidance for Industry—Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. FDA 2005. https://www.fda.gov/regulatory-information/search-fda-guidance-documents.... Accessed 4 Feb 2021.
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