FDA Approves Idacio, the Eighth Adalimumab Biosimilar

Fresenius Kabi announced the FDA approval of its adalimumab biosimilar Idacio (adalimumab-aacf), making it the eighth biosimilar referencing Humira (adalimumab) to be approved in the United States.

In January 2023, 1 adalimumab biosimilar (Amgevita) will launch on the US market, followed by up to 9 others, including Idacio, in July 2023. Upon launch, Idacio will be offered in a citrate-free, low-concentration formulation in a prefilled syringe or prefilled autoinjector pen.

“This is another important milestone for Fresenius Kabi in fulfilling our strategic priority of introducing biosimilars for patients worldwide….In the United States, we are a leading manufacturer of small-molecule injectable medicines,” said Michael Schöhnofen, PhD, chief operating officer and management board member at Fresenius Kabi, in a statement.

Idacio will be used in the treatment of patients with several chronic conditions, including rheumatoid arthritis, plaque psoriasis, Crohn disease, ulcerative colitis, psoriatic arthritis, hidradenitis suppurativa, ankylosing spondylitis, juvenile idiopathic arthritis, and uveitis. Adalimumab products are monoclonal antibodies that act as tumor necrosis factor blockers.

The biosimilar is currently available in at least 37 countries worldwide. Idacio was granted marketing authorization by the European Medicines Agency in April 2019 for use across the European Union. In February 2021, Fresenius Kabi launched Idacio on the Canadian market after receiving approval from Health Canada in October 2020.

Fresenius Kabi has not expressed plans to pursue an interchangeability designation for Idacio. Idacio is the second biosimilar developed by the Germany-based company to receive approval in the United States, following the approval of Stimufend, a biosimilar referencing Neulasta (pegfilgrastim) in September 2022. The company also has a biologics license application for a tocilizumab biosimilar candidate referencing Actemra under review and is in the early stages of development for multiple undisclosed candidates in the autoimmune and oncology spaces.

“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,” Schöhnofen commented.

Earlier this year, The Center for Biosimilars® published a multimedia series of articles and podcasts entitled “WHEN CHOICE ARRIVES: Competition & Competition.” The series explored how the US market introduction of adalimumab biosimilars in 2023 will impact each stakeholder, what the United States can learn from the experience of other global markets, what the first year of biosimilar competition in the adalimumab space could look like, and how health policy can influence adoption patterns for these products.