Humira’s dominance continues as the world’s top-selling prescription product as the biologic therapy is the first drug to exceed $20 billion in annual global sales.
Humira maintains a stranglehold on the No. 1 sales ranking among prescription medicines globally, a reign that started in 2012 after former heavyweight champion Lipitor lost U.S. marketing exclusivity during late November 2011. Available for treating various autoimmune diseases, Humira’s 2018 worldwide sales exceeded $20 billion combined between marketers AbbVie and Japan’s Eisai, with nearly $19.94 billion accounted for by the North Chicago-based biopharmaceutical company. During the first six months of 2019, AbbVie reported worldwide sales of nearly $9.32 billion while Eisai’s total came in at about $210 million.
The world’s fully human anti-TNF-α monoclonal antibody, Humira entered the U.S. marketplace during January 2003. The medicine has received FDA approval throughout the years for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.
Direct biosimilar competition in certain international markets has negatively affected Humira sales since October 2018. AbbVie has been fending off biosimilar launches in the United States until 2023.
According to EvaluatePharma’s “World Preview 2019, Outlook to 2024” report, Merck’s blockbuster anti-PD-1 therapy Keydruda will surpass Humira as the No. 1 ranked prescription drug in terms of global sales in 2024. Keytruda has received U.S. marketing clearance for 21 oncology indications as of early August 2019 spanning melanoma, non-small cell lung cancer, small cell lung cancer, head and neck cancer, classical Hodgkin lymphoma, primary lediastinal large B-cell lymphoma, urothelial carcinoma, microsatellite instability-high (MSI-H) cancer, gastric cancer, esophageal cancer, cervical cancer, hepatocellular carcinoma, Merkel cell carcinoma, and renal cell carcinoma.
“A $1.5 billion increase in sales for Humira ensured AbbVie’s blockbuster remained the top-selling product worldwide in 2018,” according to EP’s 12th annual world preview/outlook edition that was released in June 2019. “However, following a number of biosimilar launches in Europe and biosimilars set to hit the U.S. in 2023, the 2024 EvaluatePharma consensus forecast for Humira has decreased by $2.8 billion compared to that given in last year’s report. This decrease, coupled with a strong year for Keytruda in terms of product sales, positive data from ongoing clinical trials and further FDA approvals, will allow Keytruda to pip Humira to the post and take the number one spot for 2024 forecasted sales.”
Keytruda worldwide sales totaled $7.17 billion for 2018, placing the humanized monoclonal antibody as the world’s fourth best-selling Rx product according to Med Ad News’ Top 200 Medicines annual report. For first-half 2019, sales for the checkpoint inhibitor climbed up to $4.9 billion compared to $3.13 billion during the January-June 2018 period.