Fresenius Kabi Announces FDA Approval of Adalimumab Biosimilar

Earlier today, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved IDACIO (adalimumab-aacf), a biosimilar referencing HUMIRA.  IDACIO is approved for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product and, according to Fresenius, is expected to launch in the U.S. from July 2023.  As we previously reported, Fresenius announced the launch of IDACIO in Canada in February 2021.

This is the second biosimilar developed by Fresenius to receive FDA approval, following the approval of STIMUFEND in September 2022.  IDACIO is the eighth biosimilar referencing HUMIRA to receive FDA approval, following the approval of Coherus’ YUSIMRY in December 2021.

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