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Peer-Review Record

Comparative Safety Profiles of Oncology Biosimilars vs. Originators in Europe: An Analysis of the EudraVigilance Database

Cancers 2023, 15(14), 3680; https://doi.org/10.3390/cancers15143680
by Victoria Nikitina 1, Greta Santi Laurini 1, Nicola Montanaro 2 and Domenico Motola 1,*
Reviewer 1:
Reviewer 2: Anonymous
Cancers 2023, 15(14), 3680; https://doi.org/10.3390/cancers15143680
Submission received: 15 June 2023 / Revised: 11 July 2023 / Accepted: 17 July 2023 / Published: 19 July 2023
(This article belongs to the Section Cancer Therapy)

Round 1

Reviewer 1 Report

Please, see attached file

Comments for author File: Comments.pdf

Author Response

Please see the attachment.

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

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