Kirsch-Stefan, Nadine
Guillen, Elena
Ekman, Niklas
Barry, Sean
Knippel, Verena
Killalea, Sheila
Weise, Martina
Wolff-Holz, Elena
Funding for this research was provided by:
Bundesministerium für Gesundheit (2522FSB450)
Paul-Ehrlich-Institut - Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel
Article History
Accepted: 27 September 2023
First Online: 13 October 2023
Declarations
:
: Open Access funding enabled and organized by Projekt DEAL. This study was funded by the German Federal Ministry of Health (Grant no. 2522FSB450).
: This study was funded by the German Federal Ministry of Health. The authors report no potential conflicts of interest or financial disclosures that are pertinent to this article.
: The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agencies with which the authors are affiliated.
: Ethics approval is not applicable to this article as no human or animal subjects were analysed.
: Consent to participate is not applicable to this article as no human or animal subjects were analysed.
: Consent for publication is not applicable to this article as no human or animal subjects were analysed.
: The datasets analysed for clinical comparability during the current study are available in the EMA repository, which are publicly available at: ExternalRef removed. The datasets generated and/or analysed during the current study for analytical biosimilarity, marketing authorization applications and regulatory assessment reports are not publicly available due to confidentiality issues.
: Not applicable.
: NK-S, EG, NE, SB, VK, SK, MW, and EW-H wrote the manuscript. NK-S, EG, NE, and EW-H designed the research. NK-S, EG, NE, VK, and EW-H performed the research and analysed the data. NK-S and EG contributed equally to the manuscript. All authors read and approved the final manuscript.