Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS

Summary

The primary objective of this study is to demonstrate equivalence of the pharmacokinetic (PK) profile of MSB11022 administered by either an auto-injector (AI) or a pre-filled syringe (PFS) as single subcutaneous (s.c.) injection of 40 mg.

Timeline

Start

2019-07-15

Primary completion

2020-03-17

Completion

2020-03-17

Outcome

Met primary endpoint

paper The 90% CI for the three coprimary PK endpoints (Cmax, AUC0-t and AUC0-inf) were entirely contained within the predefined equivalence margins of 80-125%. PMID 35262901 ↗

Publications

• Sabet A, Dickerson DS, Kunina EE, Buccarello AL, Monnet J. A Randomised Controlled Trial Comparing the Pharmacokinetics and Tolerability of the Proposed Adalimumab Biosimilar MSB11022 Delivered via Autoinjector and Pre-filled Syringe in Healthy Subjects. Rheumatol Ther. 2022 Apr;9(2):693-704. doi: 10.1007/s40744-022-00432-1. Epub 2022 Mar 9.

Drugs

Indications