40th Biosimilar Approved: Fresenius Kabi Gets FDA’s Nod on Idacio®

On December 14, Fresenius Kabi announced that the US Food and Drug Administration approved its adalimumab biosimilar, Idacio (adalimumab-aacf). This is the eighth Humira® biosimilar approved, and Fresenius Kabi expects to launch the agent in July, along with several of its competitors.

Idacio is a citrate-free, low-concentration dose formulation of adalimumab. The company has not disclosed whether it has plans to seek approval for a high-concentration dose version in the future.

In the press release announcing the approval, Michael Schonhӧfer, CEO of Fresenius Kabi, stated, “This is another important milestone for Fresenius Kabi in fulfilling our strategic priority of introducing biosimilars for patients worldwide.”

Idacio had been marketed in the EU since 2019. This marks the second US biosimilar approval for Fresenius Kabi; Stimufend®, a pegfilgrastim biosimilar, was licensed in September 2022. the company filed the first 351(k) application for approval of a tocilizumab biosimilar in August 2022. It is also working on an investigational biosimilar for denosumab.

There are now 40 biosimilars approved since the opening of the FDA’S biosimilar 351(k) pathway in 2012.

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