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Comment
. 2021 May;35(3):373-374.
doi: 10.1007/s40259-021-00476-9. Epub 2021 Apr 16.

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"

Joerg Putzke  1 , Scott Haughie  2 , Kelly H Zou  3 , Gopinath M Ranganna  4
Affiliations
Comment

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"

Joerg Putzke et al. BioDrugs. 2021 May.
No abstract available

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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

Comment on

References

    1. Tanni KA, Truong CB, Almahasis S, et al. 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 doi: 10.1007/s40259-020-00466-3. - DOI - PubMed
    1. 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.
    1. 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.
    1. Sakaeda T, Tamon A, Kadoyama K, Okuno Y. Data mining of the public version of the FDA adverse event reporting system. Int J Med Sci. 2013;10(7):796–803. doi: 10.7150/ijms.6048. - DOI - PMC - PubMed
    1. Szarfman A, Machado SG, O'Neill RT. Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database. Drug Saf. 2002;25:381–392. doi: 10.2165/00002018-200225060-00001. - DOI - PubMed

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