Analytical Similarity Assessment of ABP 959 in Comparison with Eculizumab Reference Product

Author:

Hutterer Katariina M.,Ip Anna,Kuhns ScottORCID,Cao ShawnORCID,Wikström MatsORCID,Liu JenniferORCID

Funder

Amgen

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine,Biotechnology

Reference18 articles.

1. Soliris® (eculizumab RP) Injection, for intravenous use. Prescribing information. Alexion Pharmaceuticals, Inc. 2019. https://alexion.com/Documents/Soliris_USPI.pdf. Accessed 7 July 2020.

2. Corban MT, Duarte-Garcia A, McBane RD, Matteson EL, Lerman LO, Lerman A. Role of vascular endothelial cells and implications for risk stratification and targeted therapies. J Am Coll Cardiol. 2017;69:2317–30.

3. Soliris. Summary of product characteristics. European Medicines Agency. 2020 https://www.ema.europa.eu/en/documents/product-information/soliris-epar-product-information_en.pdf. Accessed 7 July 2020.

4. Dhara VG, Naik HM, Majewska NI, Betenbauch MJ. Recombinant antibody production in CHO and NS0 cells: differences and similarities. BioDrugs. 2018;32:571–84.

5. European Medicines Agency. Guideline on similar biological medicinal products (revision 1). 2014. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-similar-biological-medicinal-products-rev1_en.pdf. Accessed 12 Nov 2020.

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