Fresenius Kabi receives FDA approval for Humira biosimilar

Fresenius Kabi has obtained the Food and Drug Administration’s permission for its citrate-free adalimumab biosimilar Idacio for use in the treatment of chronic autoimmune diseases for all eligible indications of AbbVie’s Humira (adalimumab).

The company plans to launch the product in a self-administered prefilled syringe and a self-administered pre-filled pen (autoinjector) in July 2023.

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“This is another important milestone for Fresenius Kabi in fulfilling our strategic priority of introducing biosimilars for patients worldwide,” said Michael Schönhofen, Fresenius Kabi’s chief operating officer and member of the Fresenius Kabi management board. “In the United States, we are a leading manufacturer of small-molecule injectable medicines. This second U.S. biopharmaceutical approval serves to broaden and diversify our U.S. portfolio to bring even more value to patients, payers and healthcare providers, and to reduce the financial pressure on healthcare systems globally.”

Idacio is a tumor necrosis factor blocker. Adalimumab is a monoclonal antibody that binds TNFα and blocks its general cytokine effects. As a consequence, adalimumab modulates TNF-mediated cellular functions and is indicated for a range of autoimmune disorders.

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Idacio has been developed by Fresenius Kabi SwissBioSim, using advanced analytical methods for use in the treatment of several chronic conditions including rheumatoid arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis, psoriatic arthritis, hidradenitis suppurativa, ankylosing spondylitis, juvenile idiopathic arthritis and uveitis. Not all indications may be approved in all jurisdictions, the company said.