Multiple Switches Between Adalimumab-fkjp and Reference Adalimumab in Moderate-to-Severe Chronic Plaque Psoriasis: A Multicenter, Double-Blind, Parallel Group, Randomized Clinical Trial for Interchangeability.

ABSTRACT:

Introduction

This study was conducted to fulfill the FDA requirement for the designation of adalimumab-fkjp, an FDA-approved biosimilar, as an 'interchangeable' biosimilar to the reference adalimumab. The primary objective was to evaluate the interchangeability of adalimumab-fkjp (low concentration, 40 mg/0.8 mL) with reference adalimumab (high concentration, 40 mg/0.4 mL) by comparing adalimumab steady-state pharmacokinetics (PK) between switching and non-switching arms. The efficacy, safety, and immunogenicity were also evaluated.

Methods

In this randomized, double-blind, parallel-group study in patients with moderate-to-severe chronic plaque psoriasis (PPs) a total of 386 patients (134 F/252 M) with PPs for ≥ 6 months involving body surface area ≥ 10% and having a Psorias

SUBMITTER: Deodhar S 

PROVIDER: S-EPMC12313752 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature