Sandoz Reports the EMA Acceptance of Hyrimoz (biosimilar, adalimumab) Application
Shots:
- 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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
