Global Biosimilar Markets: Europe vs United States - Key Differences and Future Growth

When it comes to cutting healthcare costs without sacrificing effectiveness, biosimilars are one of the most powerful tools available. But how they’re adopted, approved, and used varies wildly between Europe and the United States. Even though both regions are targeting the same goal-making expensive biologic drugs more affordable-their paths couldn’t be more different.

Europe Got a 9-Year Head Start

Europe didn’t just lead the biosimilar race; it built the entire track. The European Medicines Agency (EMA) approved the world’s first biosimilar, Omnitrope (a growth hormone), in 2006. That gave European doctors, hospitals, and payers nearly a decade to get comfortable with these drugs. By the time the U.S. approved its first biosimilar, Zarxio, in 2015, Europe already had over 50 biosimilars on the market.

It wasn’t just about being first. Europe created a clear, science-based regulatory system. The EMA didn’t demand endless new clinical trials. Instead, they focused on rigorous analytical data, non-clinical studies, and targeted clinical trials only when needed. This "totality of evidence" approach made approval faster and cheaper for manufacturers.

That efficiency translated into real-world use. In countries like Germany, France, and the UK, hospital procurement systems started favoring biosimilars through competitive tenders. Pharmacists could substitute biosimilars for brand-name biologics without needing a doctor’s new prescription. In oncology and rheumatology, biosimilars now make up more than 80% of prescriptions in some European countries.

The U.S. Struggled to Catch Up

The U.S. passed the Biologics Price Competition and Innovation Act (BPCIA) in 2009, but it took six years just to get the first biosimilar approved. Why the delay? It wasn’t science. It was legal and economic roadblocks.

Originator drug companies used patent thickets-layers of overlapping patents-to block competition. They sued biosimilar makers, dragged out negotiations through the so-called "patent dance," and settled deals that delayed market entry for years. Even when a biosimilar got FDA approval, it often couldn’t launch because of legal injunctions.

Then there was the interchangeability hurdle. The FDA required biosimilars to prove they could be switched back and forth with the original drug without risk. That meant costly and time-consuming clinical switching studies. Only a handful of biosimilars ever cleared that bar.

By 2024, the U.S. had approved just over 20 biosimilars. Europe had approved more than 100. And while biosimilars accounted for nearly half of all biologic prescriptions in parts of Europe, they made up less than 10% in the U.S. - despite having a much larger biologics market.

The Game Changed in June 2024

Everything started shifting in June 2024, when the FDA proposed a major rule change: no more mandatory switching studies for interchangeable biosimilars.

This was huge. It meant the U.S. was finally moving toward the European model. If a biosimilar was shown to be highly similar to the reference product through analytical and clinical data, it could now be labeled interchangeable without running new patient-switching trials. That cut years off development timelines and slashed costs.

The change didn’t come out of nowhere. It was driven by pressure from payers, patients, and even some drugmakers who realized the old system was holding back competition. The Inflation Reduction Act of 2022 also helped by closing the Medicare Part D coverage gap, making biosimilars more attractive to insurers.

Now, biosimilar makers are rushing to file applications. More than a dozen Humira biosimilars have been approved, and several are finally launching in 2025 after years of patent battles. Pfizer, Merck, and Samsung Bioepis are all expanding their U.S. biosimilar pipelines.

Market Size: Europe Still Leads, But the U.S. Is Catching Fast

In 2024, Europe’s biosimilar market was valued at around $13 billion. The U.S. market was close behind at $10.9 billion. But growth rates tell a different story.

Europe’s market grew at about 13% annually from 2020 to 2024. The U.S. grew at 11% over the same period. But projections for 2025-2034 show the U.S. accelerating faster: 17.5% to 18.5% CAGR, compared to Europe’s 17.3%. Why? Because the U.S. is catching up.

Europe’s market is mature. Most of the easy wins-like biosimilars for growth hormone and erythropoietin-are already in place. The U.S., by contrast, is just starting to tap into the big-ticket biologics: Humira, Enbrel, Remicade, Herceptin. These drugs each generate billions in annual sales. When their patents expire, biosimilars could save the U.S. healthcare system tens of billions.

By 2027, North America (mostly the U.S.) is projected to overtake Europe in total biosimilar revenue. By 2033, the U.S. market alone could hit $30 billion. Europe will keep growing, too-projected to reach $65 billion by 2034-but the U.S. is no longer playing catch-up. It’s becoming the new frontier.

Who’s Making These Drugs?

The top biosimilar makers are global, but their focus differs by region.

In Europe, Sandoz (Novartis), Fresenius Kabi, and Amgen dominate. Germany, in particular, has become a biosimilar manufacturing hub. Companies there don’t just sell drugs-they build the entire supply chain, from cell lines to packaging.

In the U.S., Pfizer and Merck are leading the charge. Samsung Bioepis, a South Korean company, has made a major push into the American market with multiple biosimilars approved for rheumatoid arthritis and cancer. These companies aren’t just competing on price-they’re investing in manufacturing scale and distribution networks to win over insurers and hospitals.

Therapeutic Areas: Where the Action Is

The types of biosimilars approved and used also differ between the two markets.

Europe led in autoimmune diseases: drugs for rheumatoid arthritis, Crohn’s disease, and psoriasis. These are chronic conditions where patients stay on the same drug for years, making substitution easier to manage.

The U.S. started with supportive care drugs like filgrastim (used to boost white blood cells after chemotherapy). These were simpler to adopt because they were used in short-term, hospital-based settings.

Now, the U.S. is moving into the same high-value areas as Europe. With Humira biosimilars finally hitting the market in 2025, dermatology and gastroenterology are about to see a major shift. Oncology biosimilars-like those for trastuzumab and bevacizumab-are also gaining traction, especially as more hospitals adopt biosimilar formularies.

What’s Holding Both Markets Back?

Even with progress, challenges remain.

Manufacturing complex biologics is still incredibly difficult. A tiny change in cell culture conditions can alter the final product. That’s why regulators demand so much data. Even small differences can raise safety questions.

Physician and patient education is another hurdle. Many doctors still think biosimilars are "generic versions"-which they’re not. Biologics are made from living cells, not chemicals. Patients worry about switching from a drug they’ve been on for years. Clear communication and real-world data are key to building trust.

And then there’s pricing. While biosimilars launch at 15-30% discounts, they don’t always lead to lower prices for patients. Insurers sometimes just pocket the savings instead of passing them on. Without policies that force transparency or require savings to be shared, the full cost benefit won’t be realized.

The Big Picture: Cost Savings Are Real

The bottom line? Biosimilars are saving billions. In Europe, they’ve cut biologic spending by an estimated 25-40% in key therapeutic areas. In the U.S., the potential is even bigger. IQVIA estimates that biosimilars could save the American healthcare system $232 billion between 2025 and 2034, just from the biologics coming off patent.

That’s not just good for budgets. It’s good for patients. More people can get access to life-changing treatments. More hospitals can afford to treat more patients. More insurers can cover more drugs without raising premiums.

Europe showed it could be done. The U.S. is now proving it can do it faster.