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# Sandoz sBLA for Citrate-free Hyrimoz
- URL: https://www.fdaweb.com/sandoz-sbla-for-citrate-free-hyrimoz/
- Published: 2023-03-21T12:00:00.000Z
- Updated: 2026-09-14T18:21:05.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154024

FDA has approved a Sandoz supplemental BLA for citrate-free Hyrimoz (adalimumab-adaz) injection, a biosimilar version of Abbvie’s Humira, indicated for treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis. The original Hyrimoz BLA was approved in 2018\. With this approval, the company says it will offer patients reduced injection volume in a citrate-free formulation.

Approval was based on a Phase 1 pharmacokinetics (PK) bridging study comparing the FDA-approved adalimumab 50 mg/mL to the citrate-free 100 mg/mL high-concentration (HCF) formulation. “This study met all of the primary objectives, demonstrating comparable PK and showing similar safety and immunogenicity of the adalimumab 50 mg/mL and adalimumab HCF,” Sandoz says.