2023-04-04 04:35:28 ET
- The European Commission (EC) approved Novartis' ( NYSE: NVS ) citrate-free high concentration formulation (HCF; 100 mg/mL) of Hyrimoz (adalimumab), a biosimilar to AbbVie's ( NYSE: ABBV ) blockbuster drug Humira.
- Swiss pharma giant's generic unit Sandoz said the approval includes all uses covered by the reference drug — rheumatic diseases, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa.
- This formulation provides a 50% reduction in injection volume compared to the 50 mg/ml concentration and potentially decreases the number of injections needed for patients who need 80 mg/mL or higher dosing, the company added.
- The approval was backed by data from a phase 1 pharmacokinetics (PK) bridging study comparing the company's approved adalimumab 50 mg/mL2 with the 100 mg/mL (HCF).
- "With eight marketed biosimilars Sandoz is offering the broadest biosimilar portfolio and is the leading biosimilars company in Europe with more than two decades of experience," said Rebecca Guntern, Head of Region Europe, Sandoz.
- In March, the U.S. Food and Drug Administration (FDA) approved the citrate-free HCF of Hyrimoz.
For further details see:
Novartis Humira biosimilar's high concentration gets approval in EU