FDA Approves Adalimumab Biosimilar for Plaque Psoriasis, Other Chronic Conditions

The FDA has approved Fresenius Kabi’s biosimilar adalimumab-aacf (Idacio) for the treatment of several chronic dermatologic conditions. This marks the eighth biosimilar of adalimumab (Humira) to gain FDA approval.

Adalimumab biosimilars are monoclonal antibodies that act as tumor necrosis factor blockers. The biosimilar is indicated for chronic conditions such as rheumatoid arthritis, plaque psoriasis, ulcerative colitis, psoriatic arthritis, hidradenitis suppurativa, and juvenile idiopathic arthritis.

“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 chief operating officer and member of the Fresenius Kabi Management Board, in a press release. “In the United States, we are a leading manufacturer of small-molecule injectable medicines. This second US biopharmaceutical approval serves to broaden and diversify our US portfolio to bring even more value to patients, payers, and health care providers, and to reduce the financial pressure on health care systems globally.”

In July 2023, adalimumab will be available in the United States in a low-concentration formulation, in prefilled syringes or prefilled autoinjection pens. Adalimumab biosimilars are currently available in at least 37 countries worldwide.

Plaque psoriasis is the most common type of the dermatologic condition. It typically involves dry, red skin lesions covered with silvery scales. Psoriatic arthritis is a form of arthritis that affects some patients with psoriasis.

Hidradenitis suppurativa is a chronic skin condition that involves lumps under the arms or in the groin region. Skin lesions develop because of inflammation and infection of the sweat glands. Patients may develop pea- or marble-sized lumps under the skin that may be painful and can enlarge and fill with pus. These lumps typically occur when the skin rubs together, such as in the armpits, groin, and buttocks.

Fresenius Kabi also has a biologics license application for a tocilizumab biosimilar candidate currently under FDA review. It is in the early stages of development for other undisclosed candidates in the autoimmune and oncology spaces.

Reference
Fresenius Kabi receives U.S. FDA approval for biosimilar Idacio® (adalimumab). News release. Fresenius Kabi; December 15, 2022. https://www.fresenius-kabi.com/news/fresenius-kabi-receives-fda-approval-for-biosimilar-Idacio