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FDA Approves Sandoz’s Citrate-Free Adalimubab Formulation

FDA Approves Sandoz’s Citrate-Free Adalimubab Formulation

The FDA has approved Sandoz’s citrate-free high-concentration formulation of its biosimilar Hyrimoz (adalimumab-adaz) injection for seven of the approved indications of AbbVie’s Humira (adalimumab), the drug’s reference product.

Adalimumab is a tumor necrosis factor inhibitor targeting a protein that is overproduced in certain autoimmune conditions. The citrate-free formulation will lead to less pain following injection.

Humira was first approved in 2002 for rheumatoid arthritis and is currently approved for treatment of nine conditions. The drug brought in over $21 billion in sales in 2022.

The seven approved indications for the citrate-free high-concentration formulation include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.

The agency decision was based on results from a phase 1 study comparing the FDA-approved adalimumab 50 mg/mL to the citrate-free 100 mg/mL, which showed comparable pharmacokinetics, safety and immunogenicity.

Sandoz plans to launch the citrate-free high-concentration formulation on July 1.

About adalimumab

Adalimumab is a biological medicine. This means it's made from proteins or other substances produced by the body. It's used to reduce swelling (inflammation) by acting on your immune system.

Adalimumab is used to treat inflammation of the:

  • joints (rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis)

  • skin (plaque psoriasis and hidradenitis suppurativa)

  • joints and skin (psoriatic arthritis)

  • spine, causing back pain (axial spondyloarthritis and ankylosing spondylitis)
  • gut and ulcers in the lining of the gut (Crohn's disease and ulcerative colitis)

  • layer beneath the white of the eyeball (non-infectious uveitis)

Humira is the brand name of the original adalimumab medicine. There are now 5 newer versions of adalimumab, known by the brand names Amgevita, Hyrimoz, Idacio, Imraldi and Yuflyma.

March 27, 2023



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