Sandoz Reports the EMA Acceptance of Hyrimoz (biosimilar, adalimumab) Application
- The EMA has accepted the application for regulatory review of its biosimilar Hyrimoz (adalimumab) as a high concentration formulation of 100mg/mL (HCF) that comprises all indications covered by reference adalimumab incl. RA, CD, PsO, UC and uveitis
- The submission was based on the P-I bridging PK study evaluating Hyrimoz (50mg/mL2) vs Hyrimoz HCF. The study met all its primary objectives & showed comparable PK & similar safety and immunogenicity b/w Hyrimoz & Hyrimoz HCF
- The company has an established portfolio of biosimilars in immunology incl. Erelzi (biosimilar, etanercept), Zessly (biosimilar, infliximab) & Rixathon (biosimilar, rituximab). If approved, Hyrimoz, citrate-free HCF can provide low inj. volume & lower no. of inj. needed for patients who require an 80mg dosage
Ref: Sandoz | Image: Sandoz
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