Novartis Humira biosimilar's high concentration gets FDA approval

The U.S. Food and Drug Administration (FDA) approved Novartis' (NYSE:NVS) citrate-free high-concentration formulation (HCF) of Hyrimoz, a biosimilar to AbbVie's (NYSE:ABBV) blockbuster drug Humira.

Hyrimoz (adalimumab-adaz) citrate-free HCF (100 mg/mL) injection is approved for seven uses covered by the reference drug Humira (adalimumab), including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis, the company added.

The Swiss pharma giant said that following this approval, Sandoz adalimumab HCF biosimilar will offer U.S. patients reduced injection volume in citrate-free formulation.

Novartis' unit Sandoz had filed a supplemental biologics license application (sBLA) to the FDA which was accepted for review in July 2022. The company had noted that it had included the indications of reference drug Humira not protected by orphan exclusivity.

Sandoz plans to launch the Hyrimoz citrate-free HCF in the U.S. on July 1.

The FDA approval was backed by data from a phase 1 pharmacokinetics (PK) bridging study comparing the FDA-approved adalimumab 50 mg/mL to the citrate-free 100 mg/mL (HCF).

Hyrimoz was initially approved by the FDA in 2018.

SA Contributor writes: Novartis: Cautiously Optimistic, Hold