Adv Ther. 2021 Nov;38(11):5609-5622. doi: 10.1007/s12325-021-01929-x. Epub 2021 Oct 07.

Investigation of the Physicochemical and Biological Stability of the Adalimumab Biosimilar CT-P17.

Advances in therapy

Yeon Kyeong Shin, Won Yong Han, Su Jung Kim, Kwang Woo Kim, Ji Won Roh, Jae Bin Lee, Jun Seok Oh, Alain Astier

PMID: 34618346 DOI: 10.1007/s12325-021-01929-x

Abstract

INTRODUCTION: CT-P17 (Celltrion, Inc., Incheon, Republic of Korea) is a biosimilar of reference adalimumab (Humira

METHODS: This analysis was designed to evaluate the stability profile of CT-P17 compared with reference adalimumab and the currently licensed adalimumab biosimilars ABP 501 (Amjevita

RESULTS: Multiple orthogonal and complementary tests demonstrated that CT-P17 was stable for 28 days under all tested conditions, as well as for protein concentrations tested (50 vs 100 mg/mL), type of delivery device (autoinjector vs prefilled syringe), and manufacturing date (recently manufactured vs aged for 17 months). There were slight differences among products in terms of charge variants, oxidation level, purity, and number of subvisible particles; however, overall, the quality of each product was maintained over 28 days.

CONCLUSION: Our data suggest that CT-P17 may be used without any significant loss of stability when stored at 5 °C or 25 °C with 60% relative humidity for up to 28 days, and was not impacted by protein concentration tested and delivery device. Comparative stability data suggest that the appropriate maximum storage period for CT-P17 may be up to 28 days at room temperature with 60% relative humidity.

© 2021. The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.

Keywords: Adalimumab; Biosimilar pharmaceuticals; CT-P17; Drug stability; Monoclonal antibodies; Room temperature stability

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Substances

• Biosimilar Pharmaceuticals
• Adalimumab

MeSH terms

• Adalimumab*
• Biosimilar Pharmaceuticals*
• Republic of Korea

Publication Types

• Journal Article
• Research Support, Non-U.S. Gov't