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Rheumatology Biosimilars Landscape

Adalimumab was approved by Food and Drug Administration (FDA) in 2002 for the treatment of rheumatoid arthritis and, in subsequent years, gained approval for the treatment of additional conditions, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa, inflammatory bowel disease, and uveitis. In 2023, several adalimumab biosimilars from different manufacturers are anticipated to enter the US market for patient use. There are 9 FDA-approved adalimumab biosimilar products. Details of these products can be found on the FDA Biosimilar Product Information website.

A recent article published in the American Journal of Health-System Pharmacy (AJHP) highlights the impact of the market entry of adalimumab biosimilars on clinical practice with respect to clinical pharmacy implementation. Adalimumab biosimilars have several unique considerations, such as interchangeability and concentration, that will impact pharmacy practices and workflows. Understanding the various adalimumab biosimilar products available and considerations surrounding these products with regard to workflow and patient use is critical. An AJHP article entitled, Preparing for the market entry of adalimumab biosimilars in the US in 2023: A primer for specialty pharmacists is worth a review.

Here is Figure 1. Checklists for workflow considerations relating to adalimumab biosimilars from the article.

Other resources on adalimumab biosimilars can be found in the resource library


Humira. Package insert. AbbVie; 2/2021.

Food and Drug Administration. Biosimilars. Accessed June 1, 2023.

Cisek S, Choi D, Stubbings J, Bhat S. Preparing for the market entry of adalimumab biosimilars in the US in 2023: A primer for specialty pharmacists. Am J Health Syst Pharm. 2023 May 31:zxad120. doi: 10.1093/ajhp/zxad120. Epub ahead of print. PMID: 37257054.