Clinic Med Daniluk

Abstract 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.

Abstract This study aimed to demonstrate the interchangeability of biosimilar CT-P17 and European Union reference adalimumab (EU-adalimumab) in a repeated-switch scenario. In this ongoing, randomized, double-blind, active-controlled, phase 3 study, adults with moderate-to-severe plaque psoriasis received 80 mg EU-adalimumab on day 1, then 40 mg 1 week later and every other week until week 11.