FDA Approves Fresenius Kabi’s Humira Biosimilar

This is the eighth biosimilar to reference the blockbuster rheumatoid arthritis drug Humira that will launch in 2023.

The FDA has approved the Fresenius Kabi’s adalimumab biosimilar Idacio to treat patients with chronic autoimmune diseases. It references AbbVie’s Humira (adalimumab). Fresenius Kabi plans to launch the product in the United States in a self-administered prefilled syringe and a self-administered pre-filled pen (autoinjector) in July 2023. Idacio is a citrate-free formulation of adalimumab. Since its first launch in 2019, Idacio has been approved and commercialized in more 37 countries around the world.

“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,” Michael Schönhofen, Ph.D., Fresenius Kabi’s chief operating officer, said in a press release.

This is the eighth Humira to be approved and made available next year. Amgen’s Amjevita will be the first one lauched in January. The others expected to launch in the second half of the year include: Organon's Hadlima, Boehringer Ingelheim’s Cyltezo, Coherus BioSciences’ Yusimry, Viatris’ Hulio, Sandoz’ Hyrimoz, and Pfizer’s Abrilada.

Humira is a widely prescribed drug in the United States, with sales of more than $17 billion in 2021 in the Unites States alone. Specialty drug costs, including Humira, represent 2% of prescriptions, yet account for 50% of drug cost spend with continued growth anticipated and are projected to reach $505 billion by 2023. Potential savings related to biosimilars could exceed $100 billion over the next five years.

Related: Cigna, Express Scripts to Provide Humira Biosimilars as Preferred Products

Related: OptumRx to Cover Amgen’s Biosimilar of Humira

This is Fresenius Kabi’s second U.S. approval of a biosimilar. In September 2022, the FDA approved Fresenius Kabi’s biosimilar Stimufend (pegfilgrastim-fpgk) for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The company expects to launch the product as a prefilled syringe early next year. Stimufend is a biosimilar of Amgen’s Neulasta. The company is also developing on-body injector for Stimufend.