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

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

Shots:

  • The US FDA has accepted an sBLA for review of its biosimilar Hyrimoz as a high concentration formulation of 100mg/mL (HCF) that comprises all indications covered by reference adalimumab incl. RA, CD, PsO, UC & uveitis
  • The submission was based on P-I PK bridging study to evaluate Hyrimoz (50mg/mL) vs citrate-free Hyrimoz HCF. The study met all of the 1EPs & showed comparable PK & similar safety and immunogenicity b/w Hyrimoz 50mg/mL & Hyrimoz HCF
  • Hyrimoz HCF would help expand access to medicine for patients with chronic immune-mediated inflammatory diseases and if approved, Hyrimoz 100 mg/mL citrate-free HCF will be the first biosimilar product in this particular disease category in the US market

Ref: Novartis | Image: Sandoz

Click here to­ read the full press release 

Neha

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 [email protected].

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