Fresenius Kabi, a global health care company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions, announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved its citrate-free adalimumab biosimilar Idacio for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product, Humira (adalimumab).
Since its first launch in 2019, Idacio has been approved and commercialized in over 37 countries around the world. Fresenius Kabi plans to launch the product in the U.S., in a self-administered prefilled syringe and a self-administered pre-filled pen (autoinjector) starting from July 2023.
“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 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 healthcare providers, and to reduce the financial pressure on healthcare systems globally.”
The approval for Idacio® (adalimumab-aacf) is based on a review of a comprehensive data package and a totality of evidence that demonstrated similar analytical profile, pharmacokinetic, efficacy, safety, and immunogenicity to the reference adalimumab product.