GRAND ROUNDS

Humira Biosimilars: Market Impact, Cost Savings, and Future Trends

AbbVie’s Humira, the world’s best-selling biologic, lost its U.S. market exclusivity just two years ago—a pretty big event in pharmaceutical history. I was just a little medical student then, watching the drama unfold from the sidelines.

Fast forward to today, and the U.S. market has ten Humira biosimilars, slowly chipping away at Humira’s dominance.

In this article, I’ll trace Humira’s rise, examine the aftermath of its exclusivity loss, and explore what these changes mean for the broader healthcare system.

The Rise of Humira

Humira’s rise is nothing short of legendary.

Approved by the FDA in 2002, Humira quickly became AbbVie’s crown jewel, dominating the market as the go-to treatment for autoimmune conditions like rheumatoid arthritis and Crohn’s disease. Its revenue hit $21 billion globally in 2022, making it the best-selling biosimilar drug ever.

Humira’s success wasn’t just about its clinical efficacy, though. It was strategic genius.

AbbVie’s patent strategy played a pivotal role in keeping Humira at the top. The company didn’t rely on a single patent but instead built a “patent thicket,” a web of over 130 patents that effectively blocked biosimilar competition for years. By the time Humira’s original patent expired in 2016, AbbVie had already secured additional protections through minor modifications, such as high-concentration formulations, and fiercely defended them in court. These strategies allowed the company to stave off biosimilar competition in the U.S. until January 2023, while biosimilars had already entered European markets years earlier.

What finally broke AbbVie’s iron grip on Humira was a combination of regulatory shifts and legal settlements. As public scrutiny of drug pricing intensified, AbbVie reached agreements with biosimilar manufacturers to delay their U.S. launches until 2023. These settlements, while buying AbbVie some time, marked the beginning of the end of Humira’s exclusivity.

The End of Market Exclusivity: Post-Mortem Analysis

Since Humira lost market exclusivity in the U.S. in January 2023, 10 Humira biosimilars have entered the market, each strategically priced to compete with AbbVie’s dominance. These biosimilars leveraged a dual-pricing strategy—some priced close to Humira’s list price, while others undercut it by as much as 85%. This pricing strategy catered to the unique incentives of pharmacy benefit managers (PBMs), who typically profit from a percentage of the drug’s list price. The higher the list price, the greater the PBM’s revenue, making formulary decisions as much about profits as savings.

Back in January 2023, I predicted PBMs would be slow to adopt low-list-price biosimilars, and I was correct. But what I didn’t anticipate was how aggressively the largest PBMs would replace brand-name Humira with their own private-label biosimilars. For example:

• CVS Caremark (CVS Health): In April 2024, CVS Caremark removed Humira from its national commercial formularies, replacing it with low-cost biosimilar Hyrimoz, privately labeled by Cordavis, a CVS Health subsidiary.

• Express Scripts (Cigna): By June 2024, Express Scripts introduced its private-label biosimilars under Quallent Pharmaceuticals, featuring Boehringer Ingelheim’s Cyltezo and Alvotech/Teva’s Simlandi. These biosimilars, priced nearly 50% lower than Humira, replaced the brand entirely on its National Preferred Formulary for 2025.

• Cost Plus Drugs: Mark Cuban’s Cost Plus Drugs partnered with Coherus to make biosimilar Yusimry, available through PBMs like RxPreferred, offering an 85% discount compared to Humira’s list price. FYI, I recently covered Cost Plus Drug’s; read here.

• Other PBMs like Navitus and MedImpact have followed suit, incorporating biosimilars like adalimumab-adaz and Simlandi into their formularies.

So, are these biosimilars making a dent in Humira’s market share?

Somewhat.

Despite the competitive pricing and formulary shifts, adoption remains uneven. Notably, Hyrimoz Cordavis has captured 10% of the market, marking it as the most significant disruptor among Humira biosimilars thus far.

Dashevsky’s Dissection

When I wrote about this topic in January 2023, I posed three key questions about the impact of Humira losing its U.S. market exclusivity. Nearly two years later, we now have the answers:

• Will the list price of the new biosimilars be lower than Humira’s? Yes.

• Will pharmacy benefit managers (PBMs) add the new biosimilars to their formularies? Yes.

• Will the increased competition affect Humira’s market share? Yes, but the effects so far have been gradual.

Despite these trends, Humira’s U.S. market share hasn’t crumbled as quickly as one might expect. Based on historical data from its exclusivity loss in the EU, we can predict it’ll take another two years before Humira faces a significant reduction in market dominance.

A major differentiator between the U.S. and EU markets is the role of PBMs, whose reliance on high-rebate brand-name drugs like Humira creates inertia against fully embracing low-cost biosimilars.

From a cost perspective, Humira biosimilars may deliver significant savings to the healthcare system. The Samsung Bioepis biosimilar report highlighted that biosimilars, on average, reduce average sale prices (the price paid after rebates) by up to 56% within five years of market entry.

The broader implications extend beyond Humira.

As highlighted in the report, the U.S. biosimilar market is diversifying, with 57 biosimilars approved across 17 unique molecules. This competitive landscape is pushing the market towards pricing transparency and creating opportunities for private-label biosimilars, as seen with CVS’s Cordavis and Cigna’s Quallent brands. However, slower biosimilar adoption in immunology compared to oncology and supportive care underscores the need for more aggressive education and policy support to accelerate uptake.

In summary, Humira’s exclusivity loss brought a wave of biosimilars with steep discounts, slowly chipping away at its dominance. While adoption has been slower than expected, biosimilars like Hyrimoz and Yusimry are making progress. The big question now: can the healthcare system fully embrace these cost-saving alternatives, or will PBM-driven rebate models keep holding us back?

PARTNERED WITH HUDDLE+

If you’ve been looking for more detailed insights on what I write about in this newsletter, check out Huddle+, my premium membership.

You’ll get access to content like today’s newsletter, plus in-depth reports, a community, and an educational platform designed to help you stay ahead in healthcare.

For example, in my recent Huddle #Trends article, The Future of Obesity Care: GLP-1s, Compounding & Surgery TrendsI explore the evolution of weight management and where the market is heading.

Become a Huddle+ member and stay ahead.

OUTSIDE THE HUDDLE

Every week in The Huddle community, I take a quick 15-minute coffee break to go live and recap what I’m seeing in healthcare for the week, from fundraising to policy.

Check out the latest episode HERE.

Become a Community member to watch live every week.
Already part of the community? Access it here.

INSIDE THE HUDDLE

Healthcare Huddle
Sunday Newsletter

How Niches Will Shape the Crowded Weight Management Market

Huddle+
Inefficiency Insights

ICU Terms and Conditions: Managing Expectations in Critical Care

Huddle+
Huddle #Trends

Consumerism Conundrum: How Innovation is Reshaping Healthcare Access and Equity

Healthcare Providers
Residency Reflections

How I Built Healthcare Huddle: Lessons from a Resident Physician-Entrepreneur

Huddle+
Huddle University
Available for purchase without a Huddle+ membership.

A 7-step Framework for Problem-solving in Healthcare
Healthcare Huddle Masterclass: Decoding My Writing Process

Check out more exclusive coverage with a Huddle+ subscription.

Read personalized, high-quality content that helps healthcare providers lead in digital health, policy, and business. Become a Huddle+ member here.