Summary of Research: Switching Between Adalimumab Reference Product and BI 695501 in Patients with Chronic Plaque Psoriasis (VOLTAIRE-X): A Randomized Controlled Trial

Abstract

Abstract This Summary of Research overviews the results of the VOLTAIRE-X study (NCT03210259), which looked at what happened when people with plaque psoriasis continually took the adalimumab reference product (adalimumab RP; known by the brand name Humira®) or switched three times between taking the adalimumab RP and BI 695501 (adalimumab-adbm, known by the brand name Cyltezo®), an adalimumab biosimilar. The VOLTAIRE-X study showed that the pharmacokinetics of adalimumab were similar in people who stayed continuously on adalimumab RP and people who switched between adalimumab RP and adalimumab-adbm. There were no differences in effectiveness, side effects, or antibodies to adalimumab when comparing people who stayed continuously on adalimumab RP with those who switched between adalimumab RP and the adalimumab biosimilar adalimumab-adbm. On the basis of these results, adalimumab-adbm was approved by the US Food and Drug Administration (FDA) as interchangeable with adalimumab RP, meaning that a pharmacist can substitute the biosimilar adalimumab-adbm for adalimumab RP without requiring permission from the original prescriber (unless required to by state law).

Keywords

• Adalimumab
• Biosimilar
• Interchangeable
• Switching
• Chronic plaque psoriasis