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

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Abstract

Introduction

CT-P17 (Celltrion, Inc., Incheon, Republic of Korea) is a biosimilar of reference adalimumab (Humira®; AbbVie Inc., North Chicago, IL, USA), which has recently received regulatory approval from the European Medicines Agency.

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®/Amgevita®; Amgen Inc., Thousand Oaks, CA, USA) and SB5 (Imraldi®; Biogen Inc., Cambridge, MA, USA) when stored at low temperature (5 °C) or room temperature (25 °C) with 60% relative humidity for up to 28 days.

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.

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Acknowledgements

Funding

This study was funded by Celltrion, Inc. (Incheon, Republic of Korea). The preparation of the article was supported by Celltrion Healthcare Co., Ltd. Celltrion Healthcare funded the Rapid Service Fee.

Medical Writing Assistance

Medical writing support (including development of a draft outline and subsequent drafts in consultation with the authors, assembling tables and figures, collating author comments, copyediting, fact checking, and referencing) was provided by Beatrice Tyrrell, DPhil, at Aspire Scientific Limited (Bollington, UK) and funded by Celltrion Healthcare Co., Ltd. (Incheon, Republic of Korea). Dr Dong-Hyeon Kim from Celltrion Healthcare reviewed this work.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Authorship Contributions

YKS: project administration, writing—original draft, writing—review and editing. WYH: supervision, writing—original draft, writing—review and editing. SJK: investigation, writing—original draft, writing—review and editing. KWK: investigation, writing—original draft, writing—review and editing. JWR: investigation, writing—original draft, writing—review and editing. JBL: investigation, writing—original draft, writing—review and editing. JSO: investigation, writing—original draft, writing—review and editing. AA: conceptualization, writing—original draft, writing—review and editing.

Disclosures

Yeon Kyeong Shin, Won Yong Han, Su Jung Kim, Kwang Woo Kim, Ji Won Roh, Jae Bin Lee, and Jun Seok Oh are employees of Celltrion, Inc. Alain Astier have nothing to disclose.

Compliance with Ethics Guidelines

This article does not contain any studies with human participants or animals performed by any of the authors.

Data Availability

All data generated or analyzed during this study are included in this published article/as supplementary information files.

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Authors and Affiliations

  1. Biotechnological Research Division, R&D Unit, Celltrion, Inc., 20, Academy-ro 51 Beon-gil, Yeonsu-gu, Incheon, 22014, Republic of Korea

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

  2. Faculty of Pharmacy, French Academy of Pharmacy, 4, Avenue de l’Observatoire, 75004, Paris, France

    Alain Astier

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  1. Yeon Kyeong Shin
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Correspondence to Yeon Kyeong Shin.

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Shin, Y.K., Han, W.Y., Kim, S.J. et al. Investigation of the Physicochemical and Biological Stability of the Adalimumab Biosimilar CT-P17. Adv Ther 38, 5609–5622 (2021). https://doi.org/10.1007/s12325-021-01929-x

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  • DOI: https://doi.org/10.1007/s12325-021-01929-x

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