Idacio Approved as Eighth Adalimumab Biosimilar in the US

Idacio (adalimumab-aacf) is a citrate-free formulation of adalimumab developed by Fresenius Kabi and is now the eighth biosimilar of Humira (adalimumab) to be approved by the US Food and Drug Administration (FDA).

Fresenius Kabi anticipates to lunch Idacio in the US in July 2023 as self-administered prefilled syringes and self-administered prefilled pens (autoinjectors).

Idacio has already been approved and commercialized in more than 37 countries after its first launch in 2019.

“This is another important milestone for Fresenius Kabi in fulfilling our strategic priority of introducing biosimilars for patients worldwide,” said Dr. Michael Schönhofen, Fresenius Kabi’s Chief Operating Officer and Member of the Fresenius Kabi Management Board, in the company’s press release.

“In the United States, we are a leading manufacturer of small-molecule injectable medicines. This second US biopharmaceutical approval serves to broaden and diversify our US portfolio to bring even more value to patients, payers and healthcare providers, and to reduce the financial pressure on healthcare systems globally,” added Dr. Schönhofen.

Idacio is a tumor necrosis factor (TNF) blocker that blocks the production of TNF-alpha to reduce inflammation in the joints and skin. Idacio is indicated to treat a range of autoimmune disorders such as ankylosing spondylitis, Crohn’s disease, juvenile idiopathic arthritis, hidradenitis suppurativa, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis and uveitis.

There are now 40 FDA approved biosimilars in the US.

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Why is Idacio a Cost-Effective Drug?

The FDA takes an abbreviated pathway to approve biosimilars because companies with a biosimilar development program must demonstrate biosimilarity between the reference product and the prospective biosimilar, and the goal isn’t to independently establish the effectiveness and safety of the prospective biosimilar. Hence, companies that manufacture biosimilars do not need to run as many expensive clinical trials.

The price of Humira is around $7,389 for a month’s supply, which means it can cost over $88,000 to take Humira for an entire year. Although Humira is covered by most insurance plans, individual plans could differ in the amount of coverage. Individuals who do not have private insurance coverage might get Humira at a discounted price through Medicare or Medicaid.

In contrast, biosimilars of Humira like Idacio are anticipated to cost 66 percent of the price of the reference biologic drug.