In-Use Stability of SB12 (Eculizumab, Soliris Biosimilar) Diluted in Saline and Dextrose Infusion Solution after an Extended Storage Period-Reference-Cited by-同舟云学术

In-Use Stability of SB12 (Eculizumab, Soliris Biosimilar) Diluted in Saline and Dextrose Infusion Solution after an Extended Storage Period

Published:2023-08-22 Issue:4 Volume:23 Page:363-375
ISSN:1174-5886
Container-title:Drugs in R&D
language:en
Short-container-title:Drugs R D

Author:

Tak Minji^ORCID,Jeong Hawon^ORCID,Yun Jihoon^ORCID,Kim Jihyun^ORCID,Kim Soyeon^ORCID,Lee Yoonsook^ORCID,Park Su Jin^ORCID

Funder

Samsung Bioepis Co., Ltd.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology

Link

https://link.springer.com/content/pdf/10.1007/s40268-023-00433-7.pdf

Reference16 articles.

1. Soliris (eculizumab). EPAR-Product Information. Levallois-Perret, France. Alexion Europe SAS, 2012. https://www.ema.europa.eu/en/documents/product-information/soliris-epar-product-information_en.pdf. Accessed 18 Nov 2022.

2. Soliris® (eculizumab) injection, for intravenous use. Prescribing information. Boston, MA. Alexion Pharmaceuticals, Inc., 2020. https://alexion.com/documents/soliris_uspi. Accessed 18 Nov 2022.

3. Epysqli (eculizumab). EPAR-Product information. Delft, the Netherlands. Samsung Bioepis NL B.V., 2023. https://www.ema.europa.eu/en/documents/product-information/epysqli-epar-product-information_en.pdf. Accessed 26 June 2023.

4. Hang JH, Gomez RD, Bumbea H, et al. A phase III randomized clinical trial comparing SB12 (proposed eculizumab biosimilar) with reference eculizumab in patients with paroxysmal nocturnal hemoglobinuria [Poster]. Presented at the 27th European Hematology Association 2022 (EHA2022) Hybrid Congress, June 9–12, 2022. Vienna, Austria.

5. Vigneron J, D’Huart E, Demoré B. Stability studies in oncology: a marketing tool for pharmaceutical companies, a scientific mission for hospital pharmacists. Eur J Oncol Pharm. 2019;2:2. https://doi.org/10.1097/OP9.0000000000000012. (e2).