Global Biosimilar Markets: Europe vs United States - How Regulations Shape Adoption and Cost Savings

When you hear the word biosimilar, you might think it’s just another generic drug. But it’s not. Generics copy simple chemical pills. Biosimilars copy complex living-cell medicines-like those used to treat cancer, rheumatoid arthritis, and diabetes. These aren’t just copies. They’re scientifically engineered to match the original biologic drug so closely that there’s no meaningful difference in how safe or effective they are. And yet, across the Atlantic, Europe and the United States have taken wildly different paths to bring them to patients.

Europe Was First-and It Showed the Way

Europe didn’t wait. In 2006, the European Medicines Agency (EMA) approved the world’s first biosimilar, Omnitrope, a version of the growth hormone somatropin. That wasn’t a fluke. It was the start of a structured, science-backed system. The EMA created clear rules: prove similarity through rigorous lab tests, animal studies, and a few targeted human trials-not dozens of new clinical trials. They focused on the totality of evidence, not just one type of data.

That clarity changed everything. Hospitals in Germany, France, and the UK started using biosimilars in their tenders. Payers encouraged them because they cut costs by 15% to 30%. By 2024, Europe’s biosimilar market hit $13.16 billion, according to Precedence Research. In some countries, over 80% of patients with autoimmune diseases like rheumatoid arthritis now get a biosimilar instead of the original biologic. That’s not just adoption-it’s normalization.

Germany became the manufacturing hub. Companies like Sandoz, Fresenius Kabi, and Amgen built facilities there because the regulatory path was predictable. Doctors trusted them. Pharmacists substituted them without hesitation. Patients didn’t even notice the switch. That’s the power of a unified system: clear rules, early trust, and coordinated pricing.

The United States Started Late-and Got Stuck

The U.S. passed the Biologics Price Competition and Innovation Act (BPCIA) in 2009, but it took six years just to approve the first biosimilar: Zarxio, a version of filgrastim, in 2015. Why the delay? It wasn’t science. It was legal.

Big pharma companies used patent thickets-layered, overlapping patents-to block competitors. They dragged companies into court for years over something called the “patent dance,” a complicated legal process under BPCIA that often led to lawsuits instead of market entry. Even when biosimilars were approved, many stayed off shelves because of settlement deals that delayed launch.

By 2024, the U.S. had approved just over 20 biosimilars, while Europe had approved over 100 since 2006. Only six of the 14 approved Humira biosimilars were actually available in the U.S. because of legal holdups. The market was $10.9 billion in 2024-big, but far behind where it could’ve been.

And then there was interchangeability. In the U.S., a biosimilar needed to prove it could be switched back and forth with the original drug without risk. That meant extra clinical trials-switching studies-that Europe never required. Those studies cost millions and took years. Many companies just gave up.

The Turning Point: FDA’s 2024 Rule Change

In June 2024, the FDA dropped the requirement for switching studies to get interchangeable status. That was a game-changer. Suddenly, the U.S. regulatory path looked a lot more like Europe’s. No more extra trials. No more delays. Just proof of similarity-analytical data, non-clinical studies, and one clinical trial to confirm safety and effectiveness.

It’s not just about rules. It’s about momentum. With Humira’s patents expiring, 14 biosimilars rushed in. Now that interchangeability is easier, more companies are jumping in. Pfizer, Merck, and Samsung Bioepis are all expanding their U.S. pipelines. The market is projected to hit $30.2 billion by 2033, growing at 18.5% annually-faster than Europe’s projected 17.34%.

The Inflation Reduction Act of 2022 helped too. It closed the Medicare Part D coverage gap, meaning seniors pay less out-of-pocket for biosimilars. That gave payers the financial incentive to push them harder.

Why Europe Still Leads in Adoption, But the U.S. Is Catching Fast

Europe still has more approved biosimilars. It has more market share. It has deeper physician trust. But the U.S. has something Europe doesn’t: a massive, untapped biologics market.

Over 118 biologic drugs are set to lose patent protection between 2025 and 2034. That’s a $232 billion opportunity, according to IQVIA. These include top-selling drugs like Enbrel, Remicade, and Keytruda. When those come off patent, the U.S. market won’t just grow-it will explode.

Europe’s growth is steady. The U.S.’s is explosive. By 2027, North America could overtake Europe as the largest biosimilar market, with Grand View Research projecting $17.2 billion in revenue compared to Europe’s slower climb.

And the therapeutic areas are shifting. The U.S. started with supportive care drugs like filgrastim. Now it’s moving into oncology and immunology-the most expensive areas. That’s where the real savings happen.

Manufacturing and Supply Chain: Europe’s Hidden Edge

While the U.S. plays catch-up on regulation, Europe still owns the manufacturing backbone. Germany, in particular, has become the global center for biosimilar production. Why? Because the regulatory clarity attracted investment. Companies didn’t have to guess if their product would be approved. They knew the path.

Today, companies from Japan, South Korea, and the U.S. are setting up manufacturing sites in Germany-not just to sell in Europe, but to export globally. The supply chain is mature. Quality control is baked in. The U.S. is building its capacity, but it’s still playing catch-up.

What’s Next? Convergence, Not Competition

The two markets are no longer opposites. They’re converging. The FDA’s 2024 rule change mirrors the EMA’s approach. Both now accept similar data packages. Both recognize that biosimilarity doesn’t require endless trials-it requires smart science.

The big difference now? Speed. Europe built its system over 15 years. The U.S. is trying to do it in five.

Patients will win. Costs will drop. Biologics that once cost $20,000 a year are now available for $10,000 or less. That’s not just savings-it’s access. A child with juvenile arthritis, a woman with breast cancer, an elderly man with diabetes-all of them can now get life-changing treatment because biosimilars exist.

The U.S. still has hurdles: fragmented payer systems, lingering physician skepticism, and complex supply chains. But the momentum is real. The regulatory barriers are falling. The patents are expiring. And the money is flowing in.

By 2030, both markets will be giants. But the story isn’t about who’s bigger. It’s about how two different systems-one patient-first, one profit-first-ended up doing the same thing: making life-saving drugs affordable.

What This Means for Patients and Providers

If you’re a doctor: don’t wait for patients to ask. Know which biosimilars are approved and interchangeable in your state. Talk to your pharmacy about substitution policies. Many biosimilars are just as effective-and far cheaper.

If you’re a patient: ask if a biosimilar is an option. It’s not a downgrade. It’s a smarter choice. The science is solid. The safety data is strong. And the cost difference can mean the difference between staying on treatment or dropping out.

If you’re a policymaker: look at Europe’s playbook. Clear rules. Early trust. No unnecessary barriers. That’s how you scale innovation without sacrificing safety.

Key Differences at a Glance

Frequently Asked Questions

What to Watch Next

The next wave of biosimilars will target the biggest-selling biologics: Humira, Keytruda, Enbrel, and Rituxan. If the U.S. keeps its current pace, we could see 50+ new biosimilars enter the market by 2030. That’s not just competition-it’s a revolution in how we pay for medicine.

Europe showed it could be done. The U.S. is proving it can be done faster. And patients? They’re the ones who win.