Sandoz Receives EMA’s CHMP Positive Opinion of Adalimumab Biosimilar
- The EMA’s CHMP has adopted a positive opinion recommending the marketing authorization of citrate-free high-concentration formulation of biosimilar Hyrimoz (adalimumab). The authorization incl. multiple indications such as RA & Crohn's disease
- Hyrimoz was originally approved by the EC in 2018 with a concentration of 50mg/mL. If the adalimumab citrate-free HCF (100 mg/mL) formulation is approved, it offers reduced injection volume and decreases the number required for patients who need 80mg dosing. HCF will have the same auto-injector as Hyrimoz 50mg/mL
- The P-I PK bridging study met its 1EPs which showed comparable PK and similar safety and immunogenicity b/w the adalimumab 50mg/mL & 100mg/mL (HCF)
Ref: Novartis | Image: Sandoz
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