Sandoz Receives EMA’s CHMP Positive Opinion of Adalimumab Biosimilar

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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

Related News:- Sandoz Reports the US FDA Acceptance of sBLA for Review of Hyrimoz (biosimilar, adalimumab) to Treat Inflammatory Diseases

Click here to­ read the full press release 

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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.

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