Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase
Analyzing several lots of these products enabled us to capture a profile of quality characteristics for each product. Overall, the extent of variability of each quality attribute among reference products and biosimilars was revealed by this study for the first time.
Authors
- Yoshiro Saito (ORCID: https://orcid.org/0000-0002-6669-8152)
- Akiko Ishii‐Watabe (ORCID: https://orcid.org/0000-0003-2167-2263)
- Akira Harazono (ORCID: https://orcid.org/0000-0002-0307-7404)
- Masato Kiyoshi (ORCID: https://orcid.org/0000-0002-5969-8138)
- Hiroko Shibata (ORCID: https://orcid.org/0009-0002-6708-1637)
Institutions
- National Institute of Health Sciences (JP)
Publication Details
- Journal
- BioDrugs
- Published
- 2025-05-07
- DOI
- https://doi.org/10.1007/s40259-025-00722-4
- Citations
- 1
- Primary Topic
- Biosimilars and Bioanalytical Methods
- Type
- article
- Field-Weighted Citation Impact
- 0.80
Funders
- Japan Agency for Medical Research and Development