Document is current

Article History

Accepted: 7 October 2025

First Online: 3 November 2025

Declarations

:

: Monica Luque, Kristina Zhelyazkova, Laxmikant Vashishta, Masna Rai, Abid Sattar, Richard Bucknall, Steffen Leutz, and Fausto Berti are employees at Alvotech. Katarina Petrovic was an employee of Alvotech at the time of the study.

: The study was conducted in accordance with the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice guidelines, and the appropriate regulatory requirements in the countries in which the study was conducted. The protocol, its amendments, and informed consent documentation were reviewed and approved by the institutional review board(s) or independent ethics committee(s) at each study site.

: All participants gave written informed consent to participate in the study prior to undertaking any study-related examination or activity. The informed consent document was approved by each study site’s institutional review board or independent ethics committee.

: Not applicable.

: The datasets generated and/or analyzed during the current study are available from the sponsor on reasonable request.

: Not applicable.

: All authors were involved in the conception and design of the study. KZ and RB were involved in the provision of study materials and patients and acquisition of the data. ML, LV, MR, AB, SL, and FB performed the analysis and/or the interpretation of the data. All authors revised the report critically. All authors approved the final version.