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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 | Advances in Therapy

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By Elena Wolff, Clinic Med Daniluk, Kadadanamari Subbarama Reddy, Nowak Sp.K
| link.springer.com
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.
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