FDA approves Fresenius Kabi’s Idacio as eighth adalimumab biosimilar
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The FDA has approved Idacio as the eighth biosimilar to adalimumab, for all eligible indications of the reference product, clearing the way for its U.S. release in 2023 alongside a deluge of other Humira biosimilars.
Idacio (adalimumab-aacf, Fresenius Kabi) is a citrate-free biosimilar to the world’s top-selling Humira (adalimumab, AbbVie), a TNF inhibitor approved to treat patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.
“This is another important milestone for Fresenius Kabi in fulfilling our strategic priority of introducing biosimilars for patients worldwide,” Michael Schönhofen, PhD, chief operating officer and management board member at Fresenius Kabi, said in a company press release. “In the United States, we are a leading manufacturer of small-molecule injectable medicines. This second U.S. biopharmaceutical approval serves to broaden and diversify our U.S. portfolio to bring even more value to patients, payers and health care providers, and to reduce the financial pressure on health care systems globally.”
Idacio is now the eighth Humira biosimilar to earn FDA approval in the United States, following the FDA approval of Yusmiry (adalimumab-aqvh, Coherus) in December 2021. To date, none of the approved adalimumab biosimilars have reached the U.S. marketplace due to AbbVie patent protections that will remain in place until 2023.
According to Fresenius Kabi, Idacio will be available in the United States in two forms, as a self-administered prefilled syringe and a self-administered pre-filled autoinjector, starting in July 2023.
The FDA based its approval on a review of a comprehensive data package as well as the totality of evidence, which demonstrated similar analytical profile, pharmacokinetic, efficacy, safety and immunogenicity to the reference product, the company noted.
Fresenius Kabi first launched Idacio in 2019. The biosimilar has been approved and marketed in more than 37 countries, according to the company.
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