Characterization for the Similarity Assessment Between the Proposed Biosimilar SB17 and Ustekinumab Reference Product Using State-of-the-Art Analytical Methods
In summary, the overall analytical characterization and similarity assessment results show that SB17 is comparable to the EU and US ustekinumab RP in terms of structural, physicochemical, biophysical, and biological attributes.
Authors
- Seung‐Won Jung (ORCID: https://orcid.org/0000-0002-0319-4467)
- Changsoo Lee (ORCID: https://orcid.org/0000-0002-8373-8101)
- Jungmin Lee (ORCID: https://orcid.org/0000-0002-8660-9444)
- Jihoon Lee (ORCID: https://orcid.org/0000-0002-7736-027X)
- J H Hong (ORCID: https://orcid.org/0000-0002-2109-0397)
- Sung-Yong Yang
- Kwang Il Hwang
Institutions
- Samsung (South Korea) (KR)
- Samsung Pharm (South Korea) (KR)
Publication Details
- Journal
- Drugs in R&D
- Published
- 2025-01-16
- DOI
- https://doi.org/10.1007/s40268-024-00501-6
- Citations
- 2
- Primary Topic
- Biosimilars and Bioanalytical Methods
- Type
- article
- Field-Weighted Citation Impact
- 1.59
Funders
- Samsung