Comparative Safety Profiles of Oncology Biosimilars vs. Originators in Europe: An Analysis of the EudraVigilance Database
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Round 1
Reviewer 1 Report
Please, see attached file
Comments for author File: Comments.pdf
Author Response
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Author Response File: Author Response.pdf
Reviewer 2 Report
The authors performed a descriptive analysis and a disproportionality study of the data reported in EV, from 01/01/2021 to 31/12/2022 for originals and biosimilar mAbs used in oncology.
The paper is well-written and correctly structured. Please find below a few comments for your consideration:
· Authors should present the limitations of the study
· According to EMA guidelines, disproportionality signals were defined when cases were ≥5. Did the authors take this issue into consideration?
· Authors should explain why they chose only 2 years for analysis.
Author Response
Please see the attachment.
Author Response File: Author Response.pdf