Preparing for the market entry of adalimumab biosimilars in the US in 2023: A primer for specialty pharmacists

Am J Health Syst Pharm. 2023 Sep 7;80(18):1223-1233. doi: 10.1093/ajhp/zxad120.

Abstract

Purpose: The impact of the market entry of adalimumab biosimilars on clinical practices and specialty pharmacies is explained. A roadmap is also provided for how pharmacists can successfully navigate this landscape.

Summary: Biosimilars have previously been introduced as a mechanism to help curb biologic expenditures, with biosimilars undergoing an abbreviated regulatory approval process that focuses on biosimilarity and generating product competition. Adalimumab is currently the leading product in the biologics market, generating approximately $20 to $30 billion in sales worldwide consecutively from 2019 to 2021. Many adalimumab biosimilars are slated to enter the market in 2023 and become available for patient use. However, compared to other biosimilars, adalimumab biosimilars have several unique considerations, such as interchangeability and concentration, that will impact pharmacy practices and workflows. Because pharmacists embedded in clinical practices and specialty pharmacies will be significantly involved in the processes relating to adalimumab biosimilar implementation, adoption, and use, a primer on understanding the various adalimumab biosimilar products available and considerations surrounding these products with regard to workflow and patient use is critical. Several resources are also provided to help pharmacists successfully navigate the adalimumab biosimilar landscape.

Conclusion: The biosimilar landscape continues to evolve, and 2023 will see the launch of several adalimumab biosimilar products, which vary with regard to formulation, concentration, and interchangeability status. Pharmacists are well positioned to educate providers and patients about this landscape and help implement an efficient workflow to support adalimumab biosimilar adoption and use.

Keywords: adalimumab; biosimilars; inflammatory conditions; specialty pharmacy; switching.

MeSH terms

  • Adalimumab
  • Biosimilar Pharmaceuticals*
  • Humans
  • Pharmaceutical Services*
  • Pharmacists

Substances

  • Biosimilar Pharmaceuticals
  • Adalimumab