Characterization for the Similarity Assessment between Proposed Biosimilar SB12 and Eculizumab Reference Product Using a State-of-the-Art Analytical Method

Author:

Kim Hyunsoo,Hong Eunkyoung,Lee Jungmin,Hong Seokku,Kim Jihye,Cho Miju,Kim Yikwon,Yoo Taekyung

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Reference14 articles.

1. Zuber J, Fakhouri F, Roumenina LT, et al. Use of eculizumab for atypical haemolytic uraemic syndrome and C3 glomerulopathies. Nat Rev Nephrol. 2012;8:643–57.

2. US FDA. Scientific considerations in demonstrating biosimilarity to a reference product. https://www.fda.gov/media/82647/download. Accessed 26 Sep 2022.

3. US FDA. Development of therapeutic protein biosimilars: comparative analytical assessment and other quality-related considerations. https://www.fda.gov/media/159261/download. Accessed 26 Sep 2022.

4. European Medicines Agency. Soliris. Summary of product characteristics. 2020. europa.eu. https://www.ema.europa.eu/en/medicines/human/EPAR/soliris. Accessed 8 Aug 2022.

5. European Medicines Agency. Guideline on similar biological medicinal products (revision 1). 2014. europa.eu. https://www.ema.europa.eu/en/similar-biological-medicinal-products-scientific-guideline. Accessed 26 Sept 2022.

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