U.S. FDA Approves Eighth Adalimumab

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Highlights:

• Adalimumab injection products are used to relieve the symptoms of certain autoimmune disorders
• Humira is the brand name of the original adalimumab medicine, which is used as reference
• FDA has approved the eighth adalimumab biosimilar to Humira for use in 2023

Fresenius Kabi, a global health care company that specializes in pharmaceuticals, medical technologies, and nutrition products for critical and chronic conditions, announced 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.

‘Eighth Adalimumab has been approved by FDA for use 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 Sch�nhofen, 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 the eighth adalimumab 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.

Eighth Adalimumab Biosimilar

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.

What is Adalimumab?

Adalimumab is a biological medicine. It is made from proteins or other substances produced by the body. It is used to reduce swelling (inflammation) by acting on the immune system.

Humira is the brand name of the original adalimumab medicine. There are newer versions of adalimumab, known by the brand names Amgevita, Hyrimoz, Idacio, Imraldi, Yuflyma and Yusimry. These newer medicines are biosimilars. A biosimilar is a similar version of the original biological medicine. It works in the same way, by blocking part of the immune system to reduce inflammation.

If someone switches, the body should respond the same way as if they had stayed on with Humira. They should not notice any difference. Adalimumab is available on prescription. It comes as a pre-filled syringe or an injection pen that can be injected under the skin.

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.

References:

1. Fresenius Kabi receives U.S. FDA approval for biosimilar Idacio (adalimumab) - (https:www.fresenius-kabi.com/news/fresenius-kabi-receives-fda-approval-for-biosimilar-Idacio)
2. About adalimumab - (https:www.nhs.uk/medicines/adalimumab/about-adalimumab/)

Sources: Medindia

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