sBLA accepted by FDA for biosimilar Hyrimoz (adalimumab-adaz) high concentration formulation
Sandoz, announced that the FDA has accepted for review its Supplemental Biologics License Application (sBLA) for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar Hyrimoz (adalimumab-adaz).
The application includes the indications of the reference medicine Humira (adalimumab) not protected by orphan exclusivity, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
Hyrimoz 50 mg/mL was approved by the FDA in 2018. In accordance with recommendations from the FDA, Sandoz conducted a Phase I pharmacokinetics (PK) 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. Recently, the European Medicines Agency also accepted the application for Sandoz proposed Hyrimoz HCF.
Upon approval, the Hyrimoz (100 mg/mL) citrate-free HCF 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, aiming for an enhanced yet familiar patient experience.
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