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Article History

Accepted: 8 July 2026

First Online: 2 August 2026

Declarations

Conflict of interest: Taekyung Kim, Keumyoung Ahn, Taehong Park and Hyungseok Baek are employees of Celltrion, Inc., the manufacturer of CT-P16 (Vegzelma ® ). Min Jung Chang, Heungjo Kim and Hongjae Lee have received research funding from Celltrion, Inc.

Ethics approval: All clinical studies (NCT03247673, CT-P16 1.2, NCT03676192) were conducted in accordance with the ethical principles of the 1964 Declaration of Helsinki and its later amendments. Each protocol was reviewed and approved by the institutional review board or independent ethics committee at every participating site.

Consent to participate: Written informed consent was obtained from all study participants prior to enrolment in each contributing clinical study.

Consent for publication: Not applicable. The article does not contain any individual person’s identifying data.

Availability of data and material: The de-identified data that support the findings of this study may be made available from the corresponding author upon reasonable request and subject to approval by Celltrion, Inc.

Code availability: NONMEM ® control streams used for the final population pharmacokinetic model are available from the corresponding author upon reasonable request.

Author contributions: Conceptualisation: TK, MJC; methodology: TK, HK, HL, MJC; formal analysis and investigation: TK, HK, HL; conduct of the clinical studies and data acquisition: KA, TP, HB; writing (original draft preparation): TK; writing (review and editing): all authors; supervision: MJC; funding acquisition: KA, TP, HB. All authors read and approved the final manuscript.