FDA Accepts sBLA for the Biosimilar Hyrimoz

The FDA has accepted for review Novartis’ supplemental biologics license application (sBLA) for a high-concentration formulation of Sandoz’ biosimilar Hyrimoz (adalimumab-adaz). The application includes the indications of the reference medicine AbbVie’s Humira (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

If approved, the high-concentration Hyrimoz 100 mg/mL would offer reduced injection volume and potentially decrease the number of injections required for patients who need 80 mg dosing. Hyrimoz HCF will have the same auto injector as Hyrimoz 50 mg/mL.

“Should the Hyrimoz HCF be approved, we believe this important biosimilar medicine would help expand access to more patients with serious inflammatory diseases, including those who currently may not have access to it,” Keren Haruvi, president, Sandoz, head of North America, said in a press release.

The submission is supported by a phase 1 pharmacokinetics bridging study comparing Hyrimoz 50 mg/mL and citrate-free Hyrimoz HCF. This study met all of the primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity of the Hyrimoz 50 mg/mL and Hyrimoz HCF.

The FDA approved Hyrimoz 50 mg/mL in 2018.
The application for a high-concentration formulation was also recently accepted by the European Medicines Agency.

Related:Amgen Biosimilar Report: Marketplace Poised for Growth