Top 10 Immunology Drugs by Worldwide Sales in 2023

AbbVie’s Humira began facing biosimilar competition in the US in 2023. Amgen launched Amjevita, the first US biosimilar to Humira, on January 31, 2023. [Source]

AbbVie has been preparing for Humira’s loss of exclusivity for years. Its two other leading immunology medicines, Skyrizi and Rinvoq, together achieved $11.732B in 2023 sales, a $4.045B increase from 2022. [Source]

Sanofi’s Dupixent continued to grow. Update: on January 25, 2024, the FDA expanded its eosinophilic esophagitis indication to children aged 1–11 years weighing at least 15 kg. [Source]

It also had positive Phase 3 trial results for COPD in 2023, when Sanofi and Regeneron were pursuing its potential to become the first biologic approved for that condition. [Source] Update: on September 27, 2024, the FDA approved Dupixent as add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. [Source]

Finding out just how profitable a single blockbuster can be is often a challenge. Regeneron’s financials disclose the economics of its antibody collaboration with Sanofi, but do not isolate Dupixent’s standalone profit: [Source]

Since Sanofi and Regeneron are partners, Sanofi records Dupixent revenue worldwide, while Regeneron reports collaboration revenue, including its share of profits. They share US profits equally; Regeneron’s international share ranges from 35–45% on a sliding scale. [Source]

In 2023, Regeneron recorded $3.1365B as its share of profits from commercialization of antibodies under the Sanofi collaboration, after development-cost reimbursements. That figure includes Dupixent and Kevzara and cannot be doubled to establish Dupixent’s combined annual profit. [Source]

Sanofi’s 2023 annual report lists March 2031 as the US Dupixent compound-patent expiry, including its patent-term extension; protection differs by country. This does not guarantee future sales growth or a specific biosimilar launch date. Dupixent was Sanofi’s top-selling medicine in 2023. [Source]

On the other hand, J&J’s 2023 annual report anticipated US biosimilar competition for Stelara from 2025. Its $10.858B in 2023 sales accounted for approximately 20% of J&J’s $54.759B Innovative Medicine revenue. [Source]

One of the more exciting developments in immunology is the use of cell therapies for autoimmune conditions, particularly lupus.

Update: a February 2024 case series evaluated CD19 CAR T-cell therapy in 15 patients, including eight with severe lupus. The researchers reported remission in all eight lupus patients during follow-up. This small, uncontrolled study supports further investigation; it does not establish long-term safety or support a forecast of top-10 sales. [Source]

Worldwide sales by medicine: 2023, with 2022 comparison (US$ billions)
1. Humira: 14.40 in 2023; 21.24 in 2022. [Abb Vie]
2. Dupixent: 11.59 in 2023; 8.73 in 2022. [Sanofi]
3. Stelara: 10.86 in 2023; 9.72 in 2022. [JNJ]
4. Skyrizi: 7.76 in 2023; 5.17 in 2022. [Abb Vie]
5. Ocrevus: 7.10 in 2023; 6.32 in 2022. [Roche 2023] [Roche 2022]
6. Entyvio: 5.52 in 2023; 5.16 in 2022. [Takeda Annual] [Takeda 2022Nine Months] [Takeda 2023Nine Months]
7. Cosentyx: 4.98 in 2023; 4.79 in 2022. [Novartis]
8. Enbrel: 4.53 in 2023; 5.12 in 2022. [Amgen] [Pfizer]
9. Rinvoq: 3.97 in 2023; 2.52 in 2022. [Abb Vie]
10. Xolair: 3.88 in 2023; 3.68 in 2022. [Roche 2023] [Roche 2022] [Novartis]

Scope: individually reported branded medicines for inflammatory and autoimmune diseases, including multiple sclerosis. Each brand’s sales cover all its indications; they are not an estimate of spending on a single disease. Pooled immunoglobulin portfolios, vaccines and oncology medicines are excluded.

Method: calendar-year sales, translated at each year’s average ECB daily exchange rate. USD per EUR: 1.053049 in 2022 and 1.081269 in 2023; USD per CHF: 1.047775 and 1.112979; USD per JPY: 0.00765230 and 0.00712980. CHF and JPY rates are the averages of daily cross-rates against the euro. Dollar conversions are approximate. [ECB data]

Entyvio’s calendar-year revenue is calculated as the March-ended fiscal year less its April–December portion, plus the following April–December period: ¥674.293B for 2022 and approximately ¥774.156B for 2023. The latter uses Takeda’s rounded ¥619.3B nine-month disclosure. Enbrel combines Amgen’s US/Canada sales and Pfizer’s sales elsewhere; Pfizer’s international figures cover its fiscal year ended November 30. Xolair combines Roche’s US sales and Novartis’s sales elsewhere. Dupixent uses Sanofi’s worldwide sales only; Regeneron profit-sharing revenue is not added.