The Food and Drug Administration (FDA) has approved Yusimry™ (adalimumab-aqvh), a biosimilar to Humira® (adalimumab).
Yusimry, a tumor necrosis factor (TNF) blocker, is indicated for:
- Rheumatoid arthritis (RA): reducing signs/symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active RA; may be used alone or with methotrexate (MTX) or nonbiologic DMARDs.
- Juvenile idiopathic arthritis (JIA): reducing signs/symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older; may be used alone or with MTX.
- Psoriatic arthritis (PsA): reducing signs/symptoms, inhibiting the progression of structural damage, and improving physical function in adults with active PsA; may be used alone or with nonbiologic DMARDs.
- Ankylosing spondylitis (AS): reducing signs/symptoms in adults with active AS.
- Crohn disease (CD): for moderately to severely active CD in patients 6 years of age and older.
- Ulcerative colitis (UC): for moderately to severely active UC in adults.
- Plaque psoriasis (PsO): for adults with moderate to severe chronic PsO who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
The approval was based on a comprehensive data package demonstrating that Yusimry was highly similar to the reference product, Humira. Findings from CHS-1420-02 (ClinicalTrials.gov Identifier: NCT02489227), a double-blind, active-control, parallel group, multicenter, global study in patients with active, moderate to severe, chronic PsO (N=545), showed that Yusimry was equivalent to adalimumab based on the primary endpoint (75% Improvement in Psoriasis Area and Severity Index [PASI-75] at week 12). Additionally, the CHS-1420-03 trial, which assessed the pharmacokinetic bioequivalence of Yusimry to that of Humira after subcutaneous administration of a single 40mg dose, demonstrated similarity on all pharmacokinetic endpoints.
Yusimry is supplied as a 40mg/0.8mL injection in prefilled syringes. The biosimilar product is expected to launch on or after July 1, 2023.
- Coherus announces US FDA approval of Yusimry™ (adalimumab-aqvh). News release. Coherus BioSciences, Inc. Accessed December 20, 2021. https://www.globenewswire.com/news-release/2021/12/20/2355175/33333/en/Coherus-Announces-U-S-FDA-Approval-of-YUSIMRY-adalimumab-aqvh.html.
- Yusimry. Package insert. Coherus BioSciences, Inc.; 2021. Accessed December 20, 2021. https://www.coherus.com/wp-content/uploads/2021/12/YUSIMRY-Full-Prescribing-Information.pdf.
This article originally appeared on MPR