Sandoz Reports the US FDA Acceptance of sBLA for Review of Hyrimoz (biosimilar, adalimumab) to Treat Inflammatory Diseases
- The US FDA has accepted an sBLA for review of its biosimilar Hyrimoz as a high concentration formulation of 100mg/mL (HCF) that comprises all indications covered by reference adalimumab incl. RA, CD, PsO, UC & uveitis
- The submission was based on P-I PK bridging study to evaluate Hyrimoz (50mg/mL) vs citrate-free Hyrimoz HCF. The study met all of the 1EPs & showed comparable PK & similar safety and immunogenicity b/w Hyrimoz 50mg/mL & Hyrimoz HCF
- Hyrimoz HCF would help expand access to medicine for patients with chronic immune-mediated inflammatory diseases and if approved, Hyrimoz 100 mg/mL citrate-free HCF will be the first biosimilar product in this particular disease category in the US market
Ref: Novartis | Image: Sandoz
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