Fresenius Kabi receives U.S. FDA approval for biosimilar Idacio® (adalimumab)

2022-12-14

上市批准生物类似药

BAD HOMBURG, Germany I December 14, 2022 I 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.

About Idacio®, an adalimumab biosimilar

Idacio® (adalimumab), is a tumor necrosis factor (TNF) blocker tumor necrosis factor (TNF) blocker and a biosimilar to Humira®. Adalimumab is a monoclonal antibody that binds TNFα and blocks its general cytokine effects. As a consequence, adalimumab modulates TNF-mediated cellular functions and is indicated for a range of autoimmune disorders.

Idacio® has been developed by Fresenius Kabi SwissBioSim, using advanced analytical methods for use in the treatment of several chronic conditions including rheumatoid arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis, psoriatic arthritis, hidradenitis suppurativa, ankylosing spondylitis, juvenile idiopathic arthritis, and uveitis. Not all indications may be approved in all jurisdictions.

For more information about biosimilars, please visit https://biosimilars.fresenius-kabi.com

For more information about biosimilars in the U.S., please visit https://biospecialized.com

* Idacio® is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries

**Humira ® is a registered trademark of AbbVie, Inc.

Fresenius Kabi is a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. Fresenius Kabi’s product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the devices for administering these products. In the field of biosimilars, Fresenius Kabi focuses on autoimmune diseases and oncology. In 2019, the first biosimilar product by Fresenius Kabi was launched. Within transfusion medicine and cell therapies, Fresenius Kabi offers products for collection of blood components and extracorporeal therapies.

With its corporate philosophy of "caring for life", the company is committed to putting essential medicines and technologies in the hands of people who help patients and finding the best answers to the challenges they face.

Fresenius Kabi employs more than 41,000 people worldwide. In 2021, the company reported sales of more than €7.2 billion. Fresenius Kabi AG is a wholly owned subsidiary of the Fresenius SE & Co. KGaA healthcare group.

For more information visit the company’s website at www.fresenius-kabi.com

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

SOURCE: Fresenius Kabi