Evaluation of Anti-SARS-CoV-2 IgG Responses in a Clinical Study of a Biosimilar Candidate to Denosumab Using Singlicate Analysis
The established bioanalytical strategy allowed the reliable detection of COVID-19 adaptive responses in study participants. The development of anti-SARS-CoV-2 IgG responses (triggered by either a natural infection or a vaccine) did not have any clinically meaningful impact on the immunogenicity of the biotherapeutic administered in the study.
Authors
- Sandra Ribes (ORCID: https://orcid.org/0000-0002-4512-8687)
- Mandy Richter
- Celine Schelcher
- Johann Poetzl
- Natalia Krivtsova
- Kerstin Reisinger (ORCID: https://orcid.org/0000-0002-5439-3909)
- Ana Villalba-Izquierdo
Institutions
- Sanden (Japan) (JP)
- Hexal (Germany) (DE)
Publication Details
- Journal
- Drugs in R&D
- Published
- 2025-05-23
- DOI
- https://doi.org/10.1007/s40268-025-00510-z
- Primary Topic
- Biosimilars and Bioanalytical Methods
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Hexal AG