Adalimumab and the Challenges for Biosimilars

Abstract

Biologic drugs are expensive therapeutic agents and represent a large and growing segment of pharmaceutical spending. In particular, at nearly $20 billion in sales in 2018, adalimumab (Humira) dominates the worldwide biologic market, with more than twice the annual sales of the second-highest selling drug, lenalidomide (Revlimid). 1 Biosimilars have long been viewed as a solution to the high price of injectable biologic drugs like adalimumab. There are now 23 approved biosimilars in the United States with hundreds more likely under development, and the assumption is that a robust biosimilar market, once established, will substantially lower the price of biologic drugs and, consequently, spending. This appears to be happening in Europe, where biosimilar adalimumab products have led to discounts of 80% off the price of brand-name Humira. 1 However, these deep discounts from biosimilar adalimumab are not available in the United States despite US Food and Drug Administration approval for 4 biosimilars, because each biosimilar manufacturer has agreed to delay their US launch until 2023 to settle patent disputes with AbbVie (maker of Humira). 2 By then, competition from newer (ie, patent-protected) biologics could erode the market share of adalimumab. In particular, the possibility of highly effective oral biologics or

Clinical Practice of Adalimumab and Infliximab Biosimilar Treatment in Adult Patients With Crohn’s Disease

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Trends in list prices, net prices, and discounts of self-administered injectable tumor necrosis factor inhibitors

“…1 Because of their high and rising prices and their widespread use, these agents represent a large and growing segment of pharmaceutical spending in the United States. 2 Increases in list prices of TNF inhibitors are worrisome because they can hinder patient affordability and access to these essential medications, particularly in uninsured and underinsured populations. 3 There are 4 self-administered injectable TNF inhibitors available in the U.S. market-all brand drugs.…”

Biosimilars as a Future, Promising Solution for Financial Toxicity: A Review with Emphasis on Bevacizumab

“…However, the window for these biosimilars to have an impact on healthcare costs is narrowing owing to delays in market introduction and utilization. Advanced, more expensive treatments are taking the place of current biologics, lessening the financial impact of current biosimilars [ 30 ]. For biosimilars to cause significant flattening of the cost-expenditure curve, strong acknowledgment of their efficacy is needed by oncologists and their patients globally.…”