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Top 10 Best-Selling Immunology Drugs by Recent Sales Data

Top 10 Best-Selling Immunology Drugs by Recent Sales Data

The immunology drug market is a dynamic landscape driven by innovation, expanded indications and competitive strategies. From biologics to biosimilars, the top-performing drugs in this sector not only offer life-changing therapies for patients but also generate billions in revenue for pharmaceutical companies.

This blog delves into the top 10 best-selling immunology drugs based on recent sales data from 2023, spotlighting their therapeutic applications, pricing and market strategies. From long-standing champions like Humira (adalimumab) to rising stars like Dupixent (dupilumab), discover how these drugs have shaped the immunology market, their impact on patient care and what their success means for the future of immunological treatments.

Join us as we explore the critical factors behind their performance, including clinical breakthroughs and competitive challenges.

Note: When it comes to companies that report in foreign currencies, the conversion to US dollars uses the average annual exchange rates reported by the US Federal Reserve.

 

1. Humira (Adalimumab)

Humira 2023 sales: $14.404 billion

Company/developer: AbbVie

Date of first US Food and Drug Administration (FDA) approval: December 31, 2002

Indications Humira is FDA-approved for: Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.

Price of Humira: The price of two Humira subcutaneous kits (40 mg/0.4 mL each) is around $7,299.

Why it sold so well: After nine years as the world’s top-selling drug, Humira has been dethroned. Despite its patent expiring in 2016, AbbVie worked aggressively to fend off biosimilar competition, employing tactics such as creating a controversial “patent thicket” — a strategy involving numerous questionable patents to maintain market dominance and exclude rivals.

Humira’s reign ended with a significant sales decline in 2023, dropping 32 percent from the $21.2 billion it earned in 2022. The impact of biosimilar competition was especially severe in the final quarter of 2023, with global sales plummeting nearly 41 percent to $3.3 billion.

Amgen introduced Amjevita, its biosimilar to Humira, early in 2023. Thanks to a 2017 agreement with AbbVie, Amjevita enjoyed several months of exclusivity in the US market.

Despite these challenges, AbbVie isn’t giving up on Humira. At the 2023 J.P. Morgan Healthcare Conference, CEO Richard Gonzalez stated that the company was prepared to compete, having secured broad formulary access for Humira across all major payers in 2023.

Meanwhile, AbbVie is pivoting to newer immunology drugs, Rinvoq (upadacitinib) and Skyrizi (risankizumab), to offset Humira’s losses. Company executives project that these drugs will generate $16 billion in revenue in 2024 and exceed $27 billion by 2027.

 

2. Dupixent (Dupilumab)

Dupixent 2023 sales: $11.588 billion

Company/developer: Regeneron and Sanofi

Date of first FDA approval: March 28, 2017

Indications Dupixent is FDA-approved for: Adults and children six months of age and older with moderate-to-severe eczema (atopic dermatitis); maintenance treatment of moderate-to-severe eosinophilic or oral steroid-dependent asthma in adults and children six years of age and older whose asthma is not controlled with their current asthma medicines; with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled; adults and children one year of age and older with eosinophilic esophagitis (EoE); adults with prurigo nodularis (PN).

Price of Dupixent: The list price of Dupixent is $3,803.20 per carton.

Why it sold so well: Dupixent experienced robust growth in 2023, with global net sales rising by 33 percent to $11.588 billion compared to the previous year. Fourth-quarter sales alone surged by 31 percent, reaching $3.22 billion compared to the same period in 2022.

Since its FDA approval in 2017, Regeneron and Sanofi’s Dupixent has been hailed as an innovative treatment for patients with atopic dermatitis, with industry experts describing it as “life-changing.”

Over the years, Regeneron has expanded Dupixent’s approved uses, most notably into asthma. Further approvals for pediatric asthma and EoE have significantly broadened its market, driving steady annual sales growth from $2.3 billion in 2019 to $4 billion in 2020, $6.2 billion in 2021 and $9.8 billion in 2022.

Looking ahead, Dupixent’s growth trajectory shows no signs of slowing. Regeneron and Sanofi are actively pursuing FDA approval for its use in chronic obstructive pulmonary disease (COPD), which would make it the first biologic treatment approved for this condition. Analysts project this indication could add $2.5 billion in peak US sales for Regeneron and an additional $1 billion in peak sales for Sanofi in international markets.

 

3. Stelara (Ustekinumab)

Stelara 2023 sales: $10.858 billion

Company/developer: Johnson & Johnson

Date of first FDA approval: September 25, 2009

Indications Stelara is FDA-approved for: Plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.

Price of Stelara: The list price of Stelara is $25,497.12 every eight weeks for the 90 mg dose.

Why it sold so well: Stelara had a strong performance in 2023, contributing approximately 12.8 percent of J&J’s total revenue for the year. According to the company’s 2023 annual report, Stelara remains its top-selling product.

However, J&J is preparing for biosimilar competition as Stelara’s patent expired last year. Due to agreements with biosimilar manufacturers, the first ustekinumab biosimilars won’t enter the market until January 1, 2025. This includes Amgen’s biosimilar, Wezlana, which received FDA approval with an interchangeability designation in November. Following Wezlana, biosimilars from Teva, Sandoz, Celltrion and Fresenius Kabi are also slated for launch in 2025.

Despite the anticipated competition, J&J is confident its immunology drug’s decline in market share will be offset by a robust pipeline of 25 potential blockbuster products. Meanwhile, biosimilars have already entered the European market, and J&J expects this to impact Stelara’s sales during the second half of 2024.

 

4. Skyrizi (Risankizumab)

Skyrizi 2023 sales: $7.763 billion

Company/developer: AbbVie

Date of first FDA approval: April 23, 2019

Indications Skyrizi is FDA-approved for: The treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy; active psoriatic arthritis in adults; moderately to severely active Crohn’s disease in adults.

Price of Skyrizi: The list price of Skyrizi is $21,017.36 per dose.

Why it sold so well: Skyrizi, an interleukin-23 (IL-23) inhibitor, has shown clinical efficacy in treating moderate-to-severe plaque psoriasis and active psoriatic arthritis. Clinical trials have revealed that 75 percent of patients achieved 90 percent skin clearance (a Psoriasis Area and Severity Index [PASI] score of 90) within 16 weeks, with these results sustained for over a year.

Skyrizi’s targeted mechanism of action and long-lasting effectiveness have positioned it as a leading choice among modern biologics in dermatology.

In 2023, despite strong competition from biosimilars affecting Humira sales — particularly with the launch of the higher-concentration Cyltezo (adalimumab-adbm) — Skyrizi generated $7.763 billion in global revenues. This represents a remarkable growth of over 50 percent compared to 2022, making it a cornerstone of AbbVie’s immunology portfolio.

AbbVie is further reinforcing its position through strategic acquisitions, such as ImmunoGen and Cerevel Therapeutics, aimed at expanding its capabilities in oncology and neuroscience.

In addition, AbbVie continues to invest in research and development. For instance, advancements with Ubrelvy (ubrogepant) and Qulipta (atogepant) for migraine relief are projected to achieve peak sales of $3 billion. Other innovative efforts, like lutikizumab for hidradenitis suppurativa, highlight AbbVie’s dedication to diversifying its therapeutic portfolio.

Skyrizi’s success showcases AbbVie’s agility and innovation in an evolving market, cementing its leadership in immunology and supporting its long-term growth strategy.

 

5. Entyvio (Vedolizumab)

Entyvio 2023 sales: $5.280 billion

Company/developer: Takeda

Date of first FDA approval: May 20, 2014

Indications Entyvio is FDA-approved for: Ulcerative colitis in adults and Crohn’s disease in adults.

Price of Entyvio: One vial of an intravenous solution reconstituted (300 mg) is $8,666.58, and one pen of a subcutaneous solution pen-injector (108 mg/0.68 mL) is $3,119.97.

Why it sold so well: Entyvio initially received FDA approval for the treatment and maintenance of ulcerative colitis. Since then, it has gained additional approvals for subcutaneous administration, offering more flexibility for patients.

The Entyvio pen provides a convenient option for at-home use, making maintenance therapy more accessible and user-friendly.

To date, Entyvio has accumulated over one million patient-years of use worldwide, highlighting its widespread adoption and extensive clinical use.

 

6. Cosentyx (Secukinumab)

Cosentyx 2023 sales: $4.980 billion

Company/developer: Novartis

Date of first FDA approval: January 21, 2015

Indications Cosentyx is FDA-approved for: Plaque psoriasis; psoriatic arthritis; active ankylosing spondylitis; enthesitis-related arthritis; non-radiographic axial spondyloarthritis; hidradenitis suppurativa.

Price of Cosentyx: The list price of Cosentyx is $7,408.96 a month for either a 150-mg or a 300-mg dose strength self-injection package and $4,230 per intravenous infusion.

Why it sold so well: Since its launch in 2015, Cosentyx has consistently shown long-term efficacy and a reliable safety profile across five systemic inflammatory conditions. With over one million patients treated globally, its expansion into inflammatory diseases beyond psoriasis has significantly contributed to its growing sales and success.

 

7. Enbrel (Etanercept)

Enbrel 2023 sales: $4.527 billion

Company/developer: Amgen

Date of first FDA approval: November 2, 1998

Indications Enbrel is FDA-approved for: Enbrel is a tumor necrosis factor (TNF) blocker used to treat rheumatoid arthritis, polyarticular juvenile idiopathic arthritis (pJIA), psoriatic arthritis, ankylosing spondylitis and plaque psoriasis.

Price of Enbrel: The list price of Enbrel is approximately $1,850 for a weekly 50 mg dose.

Why it sold so well: Enbrel is the first biologic with published data showing sustained improvements across multiple efficacy measures for rheumatoid arthritis patients over a therapy duration of up to nine years.

In the US, the FDA has approved biosimilar versions of Enbrel, and an increasing number of companies have announced plans to develop additional biosimilar versions, signaling growing competition for Enbrel.

 

8. Xolair (Omalizumab)

Xolair 2023 sales: $3.987 billion

Company/developer: Genentech and Novartis

Date of first FDA approval: June 20, 2003

Indications Xolair is FDA-approved for: Xolair is an anti-immunoglobulin E (IgE) antibody used for several conditions: it treats moderate to severe persistent asthma in patients aged six and older who have inadequate control with inhaled corticosteroids and positive allergen tests; chronic rhinosinusitis with nasal polyps in adults over 18 who don’t respond to nasal corticosteroids; IgE-mediated food allergies in individuals aged one year and older, helping reduce allergic reactions, including anaphylaxis, when combined with food allergen avoidance; and chronic spontaneous urticaria in patients aged 12 and older who remain symptomatic despite H1 antihistamine treatment.

Price of Xolair: The list price of Xolair is around $30,000 to $60,000 annually.

Why it sold so well: On February 16, 2024, the FDA approved omalizumab for reducing allergic reactions, including anaphylaxis, due to accidental exposure to food in adults and children aged one year and older with food allergies. Clinical trials demonstrated that 68 percent of patients treated with Xolair for 16 to 20 weeks could tolerate at least 600 mg of peanut protein without moderate to severe allergic symptoms, compared to just five percent in the placebo group. Furthermore, a significantly higher proportion of Xolair-treated patients compared to placebo tolerated at least 1,000 mg of protein from milk (66 percent vs. 11 percent), egg (67 percent vs. zero percent) or cashew (42 percent vs. three percent), without moderate to severe allergic reactions.

 

9. Rinvoq (Upadacitinib)

Rinvoq 2023 sales: $3.969 billion

Company/developer: AbbVie

Date of first FDA approval: August 16, 2019

Indications Rinvoq is FDA-approved for: It is used to treat rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis and pJIA.

Price of Rinvoq: The list price for a 30-day supply of Rinvoq is $6,431.21 as of January 2024.

Why it sold so well: Rinvoq is projected to exceed $10 billion in sales by 2027, driven by its indications in rheumatology, inflammatory bowel disease (IBD) and atopic dermatitis.

In 2023, the FDA approved Rinvoq as the first oral treatment for moderately to severely active Crohn’s disease. Clinical trials demonstrated that a higher proportion of patients receiving 45 mg of Rinvoq achieved clinical remission, as measured by the Crohn’s Disease Activity Index (CDAI), than those receiving a placebo. Additionally, patients treated with 45 mg of Rinvoq showed greater improvement in intestinal inflammation, as assessed by colonoscopy, relative to the placebo group.

 

10. Orencia (Abatacept)

Orencia 2023 sales: $3.601 billion

Company/developer: Bristol Myers Squibb

Date of first FDA approval: December 23, 2005

Indications Orencia is FDA-approved for: Treating adults with moderately to severely active rheumatoid arthritis; managing moderately to severely active pJIA in patients aged two years and older; treating adults with active psoriatic arthritis; and preventing acute graft-versus-host disease (aGVHD) in adults and pediatric patients aged two years and older who are undergoing hematopoietic stem cell transplantation (HSCT) from a matched or partially mismatched unrelated donor, in combination with a calcineurin inhibitor and methotrexate.

Price of Orencia: The monthly list price for self-injected Orencia is $5,695. The list price for Orencia administered via intravenous infusion is $4,285 per dose, excluding administration costs.

Why it sold so well: In 2023, Orencia’s US revenue grew by four percent, primarily due to increased demand. International revenue rose by three percent, driven by higher demand but partially offset by a three percent negative impact from foreign currency fluctuations. Without the effect of foreign exchange, global revenue increased by six percent.

Bristol Myers Squibb has reported no Orencia biosimilars available in the US, European Union (EU) or Japan. The formulation and other related patents are expected to expire in 2026 and later.