Global Biosimilar Markets: Europe vs United States - How Regulations and Adoption Differ

Biosimilars aren’t generics. They’re not cheaper copies like aspirin or metformin. They’re highly complex, living-cell-derived medicines that mimic expensive biologic drugs-like Humira, Enbrel, or Rituxan-with no clinically meaningful difference in safety or effectiveness. But while both Europe and the United States approve these drugs, their markets couldn’t be more different. Europe has been using biosimilars for nearly two decades. The U.S. is just catching up. And that gap explains why one region saves billions each year, while the other still struggles to get them into patients’ hands.

Europe Got There First-and Built a System That Works

The European Medicines Agency (EMA) approved the world’s first biosimilar, Omnitrope, in 2006. That wasn’t an accident. Europe created a clear, science-based pathway for approval long before the U.S. did. Instead of demanding new clinical trials for every single patient group, EMA focused on rigorous analytical data, non-clinical studies, and targeted clinical trials. If the data showed the biosimilar was highly similar to the original, it got approved. No extra hoops.

That clarity changed everything. Hospitals in Germany, France, and the UK started using biosimilars in oncology and rheumatology as early as 2008. By 2024, biosimilars made up over 80% of the market for some biologics in these countries. In Germany, local manufacturers like Sandoz and Fresenius Kabi built entire production lines around biosimilars. The country became a global hub-not just for use, but for making them.

Europe didn’t rely on luck. It used structured pricing. Hospitals ran tenders: if you want to supply our cancer center, your biosimilar has to be cheaper than the brand. And in many countries, pharmacists could automatically substitute biosimilars for brand-name drugs without needing a new prescription. That’s called interchangeability-and Europe made it routine.

By 2024, Europe’s biosimilar market hit $13.16 billion in revenue, growing at 13% annually since 2020. It’s the largest biosimilar market in the world right now. And it didn’t happen overnight. It happened because regulators, hospitals, doctors, and payers all moved in the same direction.

The U.S. Started Late-and Got Stuck

The U.S. passed the Biologics Price Competition and Innovation Act (BPCIA) in 2009. Sounds promising, right? But the law was full of loopholes. It created a legal maze called the “patent dance,” where originator companies could drag biosimilar makers into years of lawsuits over patents. Some of these lawsuits had nothing to do with real intellectual property-they were just tactics to delay competition.

It worked. The first U.S. biosimilar, Zarxio (a version of filgrastim), didn’t get approved until 2015. Even then, it took years before it was widely used. Why? Because doctors didn’t trust them. Payers didn’t push them. And the FDA required something Europe didn’t: switching studies.

Switching studies meant proving that patients could safely switch back and forth between the brand and the biosimilar multiple times. That’s not medically necessary. Biologics don’t work like antibiotics-you don’t need to cycle them. But the FDA made it a requirement for interchangeability status. That meant biosimilar companies spent millions on extra trials just to get one extra label. Many didn’t bother.

By 2024, Europe had approved over 100 biosimilars. The U.S. had approved just 20. And only a handful were actually available on pharmacy shelves. The rest were blocked by patent settlements. For example, Humira, the world’s top-selling drug, lost its patent in 2023. Fourteen biosimilars were approved in the U.S.-but only six were on the market because the original maker, AbbVie, signed deals to delay their launch.

Things Are Changing Fast in the U.S.

In June 2024, the FDA dropped the switching study requirement for interchangeability. That was a game-changer. Suddenly, the U.S. regulatory path looked a lot more like Europe’s. Companies could now focus on proving similarity-not proving patients could switch safely.

That change, combined with the Inflation Reduction Act of 2022, is turbocharging adoption. The IRA eliminated the Medicare Part D coverage gap, meaning seniors pay less out of pocket for high-cost drugs. It also created financial incentives for Medicare to favor biosimilars. Suddenly, payers had a reason to push them.

The numbers show it. The U.S. biosimilar market hit $10.9 billion in 2024, up from $7.1 billion in 2020. Projections show it could hit $30 billion by 2033. That’s an 18.5% annual growth rate-faster than Europe’s 17.3%. The U.S. isn’t just catching up. It’s accelerating.

Why? Because the U.S. has more to gain. Over 118 biologics are set to lose patent protection between 2025 and 2034. That’s a $232 billion opportunity. Humira’s biosimilars are just the start. Drugs like Enbrel, Remicade, and Lantus are next. When those come off patent, the floodgates will open.

Who’s Winning? Europe Still Leads, But the U.S. Is Closing In

Right now, Europe still has the bigger market. But the U.S. is growing faster. North America (mostly the U.S.) is projected to overtake Europe in market size by 2027. Why? Because the U.S. has more high-revenue biologics coming off patent. Europe’s biggest biosimilar opportunities came earlier. The U.S. is just entering its golden age.

Manufacturing is still stronger in Europe. Germany, France, and Switzerland have decades of experience making complex biologics. But U.S. companies like Pfizer, Merck, and Samsung Bioepis are investing billions to build their own capacity. They’re not just importing biosimilars-they’re making them here.

Therapeutic areas are shifting too. Europe led in autoimmune diseases-rheumatoid arthritis, Crohn’s, psoriasis. The U.S. started with supportive care drugs like filgrastim (used after chemotherapy). Now, it’s moving into oncology and diabetes. The same drugs. The same science. Just a slower start.

What’s Holding Back Biosimilars Everywhere?

Even with progress, barriers remain. Doctors still don’t always know the difference between biosimilars and generics. Many think they’re “inferior.” Patients are nervous. One study found that nearly half of rheumatologists still prefer the brand-name drug-even when the biosimilar is cheaper and equally effective.

Education is the missing piece. In Europe, health agencies ran campaigns to explain biosimilars to doctors. In the U.S., that hasn’t happened at scale. There’s no national plan to teach providers how to talk to patients about switching.

Manufacturing is another challenge. Biosimilars are made from living cells. One tiny change in the process can alter the molecule. That’s why regulators require so much data. But as new, more complex biologics come out-like cell and gene therapies-making biosimilars will get even harder.

And then there’s pricing. In Europe, biosimilars typically launch at 15-30% discounts. In the U.S., they’ve often launched at 50% or more. That’s great for savings-but it also means companies are fighting over a shrinking pie. Some worry that if prices drop too fast, manufacturers won’t make the investment to keep producing them.

What’s Next?

The future of biosimilars isn’t about which region wins. It’s about how fast both can bring down the cost of life-saving drugs.

Europe’s model proves it’s possible. Clear rules. Strong support. Trust from providers. Rapid adoption. The U.S. is learning from that. With the FDA’s 2024 guidance change and the Inflation Reduction Act, the U.S. now has the tools to match Europe’s success.

By 2030, biosimilars could save the U.S. healthcare system over $100 billion. That’s money that could pay for cancer treatments, insulin for diabetics, or mental health care for millions who can’t afford it now.

The science is there. The regulators are aligned. The patents are expiring. The only thing left is for doctors, payers, and patients to catch up.