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.

ABSTRACT:

Introduction

The aim of the study was to demonstrate the bioequivalence, and compare the safety and tolerability of MSB11022, a proposed biosimilar of adalimumab, when delivered by either an autoinjector (AI) or a pre-filled syringe (PFS).

Methods

In this pharmacokinetic (PK), parallel group, open-label study, 216 healthy volunteers were randomised 1:1 to receive a single subcutaneous injection of a 40 mg/0.8 mL dose of MSB11022 administered via AI or PFS. Coprimary PK endpoints were maximum observed concentration (C_max), area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC_0-t), and AUC from time 0 extrapolated to infinity (AUC_0-inf). PK equivalence between the AI and PFS administration methods

SUBMITTER: Sabet A 

PROVIDER: S-EPMC8964896 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature