Overview of Humira® Biosimilars: Current European Landscape and Future Implications

• Published in: Journal of pharmaceutical sciences Vol. 110; no. 4; pp. 1572 - 1582
• Main Authors: Coghlan, Jill, He, Hongliang, Schwendeman, Anna S.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.04.2021
• Subjects: Adalimumab; Antibody drug(s); Biosimilar Pharmaceuticals; Biosimilar(s); Clinical trial(s); Europe; Formulation; Humans; Physicochemical properties; United States; United States; Europe; Biosimilar(s); Antibody drug(s); Clinical trial(s); Formulation; Physicochemical properties
• ISSN: 0022-3549; 1520-6017
• DOI: 10.1016/j.xphs.2021.02.003

Humira® (adalimumab) by AbbVie has been the top-selling biologic drug product for the last few years – reaching nearly $20 billion in annual sales in 2018. Upon the October 2018 release of four adalimumab biosimilars into the European market, those sales began to shrink. By the end of 2019, the annual sales of Humira®, albeit still high, dipped closer to $19 billion as nearly 35% of European patients had been switched from Humira® to a biosimilar. Diminishing sales are expected to continue as the adoption of adalimumab biosimilars increases in Europe and Humira®’s patent protection is lost in the United States come 2023. In this review we discuss how impactful the availability of biosimilars has been to the European adalimumab market approximately two years after their release. We further analyze the marketed biosimilars with regards to differences in their formulation, delivery devices, biological activity, physicochemical properties, clinical trials data, and current financial foothold. More importantly, though, we highlight how “similar” these biosimilars are to Humira®. In doing so, we seek to educate the public on what they may be able to expect once adalimumab biosimilars enter the United States market in 2023.