Sandoz’s Hyrimoz (biosimilar, adalimumab) Receives EC’s Marketing Authorization for Multiple Indications
- The EC has granted marketing authorization for Hyrimoz (adalimumab-adaz) high-concentration formulation, a biosimilar to Humira (adalimumab) in the EU. Hyrimoz has been approved for use in all the indications covered by the reference Humira, incl. PsO, RA, UC, CD, uveitis & hidradenitis suppurativa
- The results from a P-I PK bridging study evaluating adalimumab (50mg/mL) vs citrate-free HCF (100mg/mL) showed that the study met all of the primary objectives confirming similar safety, immunogenicity & PK of Hyrimoz 50mg/mL & the high-concentration formulation
- Sandoz continues to expand patient access to much-needed medications, increase healthcare savings, and fuel innovation through increased competition
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