FDA Approves Citrate-Free Adalimumab Biosimilar for Plaque Psoriasis, Other Autoimmune Diseases

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This newly-approved monoclonal antibody was developed as a citrate-free formulation of adalimumab.

This week, the US Food and Drug Administration (FDA) approved an adalimumab biosimilar known as adalimumab-aacf (Idacio), intended for treatment of chronic autoimmune diseases such as plaque psoriasis and Crohn’s disease.

The new formulation of adalimumab by Fresenius Kabi SwissBioSim is a monoclonal antibody designed to bind TNFα and then block the cytokine effects, and it is free of citrate.

The new drug’s commercial launch in the US is slated for 2023. Beginning in July, the company stated its intention to allow patients to choose between either a self-administered and prefilled syringe or a self-administered pre-filled autoinjector for administration of the product.

“This is another important milestone for Fresenius Kabi in fulfilling our strategic priority of introducing biosimilars for patients worldwide,” said Michael Schönhofen, PhD, chief operating officer and member of the Fresenius Kabi Management Board.

This TNF inhibitor’s approval resulted from a comprehensive analysis of evidence that indicated adalimumab-aacf’s similar analytical profile, immunogenicity, safety, and efficacy to the reference product, Fresenius Kabi officials noted.

“In the United States, we are a leading manufacturer of small-molecule injectable medicines,” Schönhofen stated. “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.”