Which is the most successful biologic drug: A look at top performers past and present

For over a decade, Humira (adalimumab) dominated the pharmaceutical market, achieving peak annual sales of more than $20 billion, but its reign is over. Determining which is the most successful biologic drug requires examining metrics beyond just peak sales, considering factors like clinical impact, therapeutic area, and market longevity. This article explores the biggest names in biologics, comparing historical and recent successes.

Quick Summary

This overview compares biologics like Humira and Keytruda to determine the most successful, considering factors such as peak and current sales, therapeutic impact, and market resilience against biosimilars.

Key Points

• Historical Dominance: Humira (adalimumab) was historically the most successful biologic, with over $200 billion in lifetime sales before biosimilar competition began impacting its revenue in 2023.

• Current Sales Champion: Keytruda (pembrolizumab) is the top-selling biologic and overall drug, generating nearly $30 billion in 2024, driven by its extensive use in oncology.

• Success is Multifaceted: Defining the 'most successful' drug depends on the metric used—whether it's peak revenue, current sales, number of patients treated, or clinical impact across multiple conditions.

• Biosimilar Impact: The emergence of biosimilars is a major market factor, causing significant revenue declines for older blockbusters like Humira while creating new market opportunities for competitors.

• Next-Generation Success: AbbVie's new biologic, Skyrizi, has seen exceptional growth and is positioned to fill the void left by Humira's market decline, showcasing the ongoing evolution of the immunology market.

• Beyond Sales: The success of biologics also lies in their ability to treat a wider range of conditions and provide targeted, effective therapy where traditional drugs fail, as seen with Keytruda in cancer and Dupixent in immunology.

Defining success in the biologics market

Determining a single 'most successful' biologic is complex and depends on the criteria used for evaluation. Key metrics can include peak lifetime revenue, current annual sales, broadness of therapeutic indications, and clinical impact on patients. The emergence of biosimilars also significantly impacts the financial success and market dynamics of originator biologics.

Humira: The historical record-breaker

For many years, AbbVie's Humira (adalimumab) was considered highly successful, generating over $200 billion in revenue since its 2003 launch and treating millions for autoimmune and inflammatory conditions. Its success stemmed from broad indications, patent protections, and strong patient support. However, US market exclusivity ended in 2023, causing sales to plummet by 2024 and allowing other drugs to surpass it in annual revenue.

Keytruda: The current revenue champion

Merck's Keytruda (pembrolizumab) is currently the world's best-selling drug by annual sales, generating nearly $30 billion in 2024. Primarily used in oncology, Keytruda treats numerous cancers like lung and melanoma. Its success is driven by its dominance in immuno-oncology with over 40 indications and its innovative approach to cancer treatment. However, its patents are expected to expire around 2028.

Other major biologic success stories

Beyond Humira and Keytruda, several other biologics have made significant market impacts:

• Dupixent (dupilumab): With sales over $13 billion in 2024, Dupixent (Sanofi/Regeneron) treats inflammatory conditions like eczema and asthma.
• Skyrizi (risankizumab): An AbbVie product, Skyrizi's sales exceeded $11 billion in 2024, treating conditions like psoriasis and Crohn's disease and gaining market share as Humira's exclusivity ended.
• Ozempic (semaglutide): Novo Nordisk's Ozempic, a GLP-1 receptor agonist, reached nearly $17 billion in sales in 2024, highlighting the success of therapies for chronic conditions like diabetes and weight management.

Comparison of top biologic drugs

Metric	Humira (adalimumab)	Keytruda (pembrolizumab)	Dupixent (dupilumab)	Skyrizi (risankizumab)
Therapeutic Area	Immunology	Oncology	Immunology, Respiratory	Immunology
Peak Annual Sales	~$20B+ (2022)	~$30B (2024)	~$13B (2024)	~$11.7B (2024)
Key Indications	RA, psoriasis, Crohn's, UC	Various cancers (lung, melanoma, etc.)	Atopic dermatitis, asthma, COPD	Plaque psoriasis, Crohn's, UC
Patent Exclusivity	Expired (2023 in US)	Looming expiration (c. 2028 in US)	Stable (c. 2031 in US)	Stable (c. 2031 in US)
Current Market Trajectory	Declining due to biosimilars	Market leader, growing	Strong growth	Strong growth, replacing Humira

Conclusion: The evolving landscape of biologic success

Defining the 'most successful biologic drug' is dynamic, influenced by market shifts and clinical needs. While Humira set a historical financial benchmark, Keytruda currently leads in annual revenue due to its vital role in cancer therapy. The success of biologics like Dupixent and Skyrizi, along with biosimilars, shows a competitive market. Success can be measured by enduring clinical value and improving patient lives, not just sales figures.

For more information on the history and development of biologics, the National Institutes of Health (NIH) website is an excellent resource for publications on clinical trials and drug success factors.

Frequently Asked Questions

Was Humira the most successful biologic drug?

Yes, historically, Humira (adalimumab) was widely considered the most successful biologic and the most financially successful drug of all time, generating over $200 billion in revenue from 2003 until biosimilar competition began affecting its market in 2023.

Which biologic is currently the best-selling?

Based on 2024 sales data, Merck's Keytruda (pembrolizumab) is currently the best-selling biologic drug and the highest-grossing pharmaceutical product globally.

How does Keytruda's success compare to Humira's?

While Humira holds the record for highest all-time total revenue, Keytruda has surpassed Humira in annual sales since 2023. Keytruda's success is focused on oncology, while Humira's was in immunology.

What caused Humira's market share to decline?

Humira's market share and sales have declined significantly since 2023 due to the expiration of its key patents and the subsequent entry of multiple biosimilar competitors in the US market.

What is AbbVie's replacement for Humira?

AbbVie's strategy to replace Humira's revenue relies on newer immunology drugs, primarily Skyrizi (risankizumab) and Rinvoq (upadacitinib). Skyrizi has shown significant sales growth since Humira's patent expired.

Are sales the only measure of a biologic's success?

No, sales are just one metric. Success can also be measured by clinical impact, the number of conditions a drug can treat, improvements in patient quality of life, and longevity in the market before losing exclusivity.

What are some other highly successful biologics?

Other successful biologics include Dupixent (dupilumab) for eczema and asthma, Stelara (ustekinumab) for inflammatory diseases, and Ozempic (semaglutide) for diabetes and weight loss, based on their strong sales and clinical impact.