The Food and Drug Administration (FDA) has approved Idacio® (adalimumab-aacf), a citrate-free biosimilar to Humira® (adalimumab).

Idacio is a tumor necrosis factor indicated for:

  • Rheumatoid arthritis (RA): reducing signs/symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA; may be used alone or with methotrexate (MTX) or other non-biologic DMARDs.
  • Juvenile idiopathic arthritis (JIA): reducing signs/symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older; may be used alone or with MTX.
  • Psoriatic arthritis (PsA): reducing signs/symptoms, inhibiting the progression of structural damage, and improving physical function in patients with active PsA; may be used alone or with non-biologic DMARDs.
  • Ankylosing spondylitis (AS): reducing signs/symptoms in adult patients with active AS.
  • Crohn disease (CD): moderately to severely active CD in patients 6 years of age and older.
  • Ulcerative colitis (UC): moderately to severely active UC in adult patients.
  • Plaque psoriasis (PsO): treating adult patients with moderate to severe chronic PsO who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

The approval for Idacio was based on a review of data that included a totality of evidence showing similar pharmacokinetics, efficacy, safety, and immunogenicity to the reference adalimumab product.


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Idacio is supplied as 40mg/0.8mL in single-dose prefilled pens (Idacio Pen) and single-dose prefilled syringes. The product is expected to be available in July 2023.

References

  1. Fresenius Kabi receives US FDA approval for biosimilar Idacio® (adalimumab). News release. Fresenius Kabi. December 14, 2022. Accessed December 19, 2022. https://www.fresenius-kabi.com/news/fresenius-kabi-receives-fda-approval-for-biosimilar-Idacio.
  2. Idacio. Package insert. Fresenius Kabi; 2022. Accessed December 19, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761255s000lbl.pdf.

This article originally appeared on MPR