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

Biosimilars aren’t generics. That’s the first thing to understand. Generics copy simple chemical drugs - pills you swallow. Biosimilars copy complex biologic drugs - living-cell-based treatments made in bioreactors, often injected or infused. These are drugs for cancer, rheumatoid arthritis, diabetes, and other serious conditions. And while they cost far less than the original biologics, their path to market is anything but simple. Europe and the United States took wildly different roads to get here - and now, they’re on a collision course.

Europe Was First - and It Stayed Ahead

Europe didn’t just lead the biosimilar race. It built the entire track. In 2006, the European Medicines Agency (EMA) approved Omnitrope, the world’s first biosimilar. That wasn’t an accident. The EMA had already laid out a clear, science-based framework for approval: prove similarity through detailed lab tests, animal studies, and limited human trials. No need for massive, expensive phase III trials comparing every single patient outcome. Just show the molecule behaves the same way - and it’s approved.

That clarity changed everything. Hospitals in Germany, France, and the UK started using biosimilars in bulk. Tenders favored lower-cost options. Doctors trusted the data. Patients didn’t resist. By 2024, Europe’s biosimilar market hit $13.16 billion. In some countries, over 80% of patients with autoimmune diseases like rheumatoid arthritis are now treated with biosimilars instead of the original biologic. Sandoz, Fresenius Kabi, and Amgen became household names in European hospitals. Germany, in particular, turned into a manufacturing hub - not just using biosimilars, but making them for the whole world.

The United States Took a Detour

The U.S. didn’t approve its first biosimilar until 2015 - nine years after Europe. Why? Because the system was broken from the start. The Biologics Price Competition and Innovation Act (BPCIA) of 2009 was supposed to create a path for biosimilars. But it came with a minefield: patent lawsuits, legal battles called the “patent dance,” and a regulatory bar so high that few could clear it.

The FDA demanded more clinical data than Europe. It insisted on switching studies - proving that patients could safely jump from the original drug to the biosimilar and back again. That wasn’t just expensive. It was unnecessary. No one was asking for switching studies for generics. But for biosimilars, the FDA said yes. And originator companies? They fought back. With deep pockets and long patent portfolios, they delayed market entry for years. By 2024, the U.S. had approved only about 20 biosimilars. Europe had approved over 100.

And it showed in the numbers. While Europe’s market grew steadily at 13% a year, the U.S. lagged. Even though the U.S. has a much larger biologics market - with drugs like Humira bringing in billions - adoption was slow. Only six of the 14 approved Humira biosimilars were actually on the market in 2024. The rest were stuck in legal limbo.

The Turning Point: FDA Changes in 2024

Everything changed in June 2024. The FDA dropped the requirement for switching studies to gain “interchangeable” status. That’s huge. Interchangeable means a pharmacist can swap the biosimilar for the brand-name drug without asking the doctor. In Europe, that’s standard. In the U.S., it was nearly impossible.

That single change unlocked the door. Suddenly, biosimilar makers could get to market faster and cheaper. Pfizer, Merck, and Samsung Bioepis started pushing new products. The Inflation Reduction Act of 2022 helped too - by closing the Medicare Part D coverage gap, it made biosimilars more attractive to insurers. Now, the U.S. market is growing at 18.5% a year. By 2033, it could hit $30.2 billion. Europe’s growth is slower - around 17.3% - but still strong.

Why the U.S. Might Soon Outpace Europe

Europe has a head start. But the U.S. has something Europe doesn’t: a tidal wave of expiring patents. Between 2025 and 2034, 118 biologic drugs will lose patent protection. That’s a $232 billion opportunity. Humira is just the beginning. Drugs for psoriasis, Crohn’s disease, and type 2 diabetes are next. And with the FDA now aligned more closely with EMA’s science-first approach, U.S. companies are moving fast.

North America is projected to overtake Europe in market size by 2027. Why? Because the U.S. market is catching up - and it’s bigger. Europe’s growth is steady. The U.S. is accelerating. The U.S. also has more private payers and pharmacy benefit managers (PBMs) pushing for cost savings. Once biosimilars hit formularies, adoption spikes.

Therapeutic Areas: Where Each Region Leads

Europe’s strength? Autoimmune diseases. Biosimilars for adalimumab, infliximab, and etanercept dominate. In Germany, over 90% of new patients get biosimilars for rheumatoid arthritis. In the U.S., adoption started with supportive care - drugs like filgrastim for low white blood cell counts after chemotherapy. Those are simpler biologics. Now, the U.S. is moving into the same complex areas as Europe: monoclonal antibodies for cancer and autoimmune disorders.

The difference? Europe’s doctors have 18 years of experience. U.S. doctors are learning fast. Patient education is catching up. More hospitals are training staff. More insurers are covering biosimilars without restrictions. The gap is closing.

Manufacturing and Supply Chain

Europe still leads in manufacturing. Germany, Ireland, and Sweden host major biosimilar production sites. Companies like Sandoz and Fresenius Kabi have built decades of expertise. The U.S. is playing catch-up. But with new FDA rules and massive investment from Pfizer and Merck, U.S.-based manufacturing is rising. Samsung Bioepis, a South Korean company, already produces biosimilars for both markets - showing how global the supply chain has become.

What’s Next? Cost Savings and Patient Access

Biosimilars aren’t just cheaper. They’re life-changing. A single biologic for rheumatoid arthritis can cost $20,000 a year. The biosimilar? $12,000. That’s a 40% drop. Multiply that across millions of patients, and you’re talking billions saved. In Europe, that’s already happening. In the U.S., it’s just starting.

The next challenge? Making sure patients get these drugs - not just hospitals. Insurance formularies still favor brand-name drugs in many cases. Doctors still default to the original because they’re unfamiliar with biosimilars. But with more approvals, more data, and more payer incentives, that’s changing.

The global biosimilar market will hit $176 billion by 2034. Europe and the U.S. will drive most of that growth. Europe won the first leg of the race. The U.S. is winning the sprint now.

What This Means for Patients

If you’re on a biologic drug - whether it’s for diabetes, cancer, or an autoimmune disease - biosimilars are coming. And they’re safe. The science is solid. The regulatory standards are tight. The only question is: when will your doctor offer you one?

Don’t assume your treatment won’t change. Ask. If you’re in the U.S., ask about interchangeable biosimilars. If you’re in Europe, ask if your current treatment is a biosimilar. Either way, you’re not just getting a cheaper drug. You’re getting the same medicine - at a price your wallet can handle.