FDA Approves Adalimumab-aacf for Plaque Psoriasis, Hidradenitis Suppurativa and Other Conditions

The US Food and Drug Administration has approved adalimumab-aacf (Idacio) for the treatment of a number of chronic dermatologic conditions. In July 2023, adalimumab will be offered in a low-concentration formulation, in prefilled syringes or prefilled autoinjection pens, in the United States. This biosimilar can be used for a wide variety of chronic conditions, including rheumatoid arthritis, plaque psoriasis, ulcerative colitis, psoriatic arthritis, hidradenitis suppurativa, juvenile idiopathic arthritis, and other conditions.

Hidradenitis suppurativa is a chronic skin condition featuring lumps under the arm or in the groin area.The skin lesions develop as a result of inflammation and infection of sweat glands. It features pea- to marble-sized lumps under the skin that can be painful and tend to enlarge and drain pus. They usually occur where skin rubs together, such as in the armpits, groin, and buttocks.
Plaque psoriasis is the most common type of psoriasis. It usually causes dry, red skin lesions (plaques) covered with silvery scales. Psoriatic arthritis is a form of arthritis that affects some people who have psoriasis — a disease that causes red patches of skin topped with silvery scales. Adalimumab biosimilars are monoclonal antibodies that act as tumor necrosis factor blockers.

The company also has a biologics license application for a tocilizumab biosimilar candidate under review, and is in the early stages of development for other undisclosed candidates in the autoimmune and oncology spaces.

Adalimumab was developed by Fresenius Kabi, a German health care company specializing in a variety of medicines and technology. Fresenius Kabi has developed a number of generic IV drugs, infusion therapies and clinical nutrition products as well as the devices for administering these products. In the field of biosimilars, the company 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 also offers products for collection of blood components and extracorporeal therapies.

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