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

Biosimilars aren’t generics. They’re not cheap copies of pills you can swap out like aspirin for ibuprofen. These are complex, living drugs made from living cells - exact replicas of expensive biologic treatments like Humira, Enbrel, or Avastin. And while both Europe and the United States approve them, how they’re adopted, priced, and trusted couldn’t be more different.

Europe Got There First - and It Showed

Europe didn’t wait. When the European Medicines Agency (EMA) launched its biosimilar pathway in 2006, it was the first in the world. The first biosimilar, Omnitrope (a growth hormone), hit the market that same year. Since then, Europe has approved over 100 biosimilars. Germany, France, and the UK led the charge, not because they were more innovative, but because they built systems that made biosimilars easy to use.

Hospital procurement systems in Europe work on tenders. If a biosimilar can prove it’s just as safe and effective - and costs 20% less - hospitals switch automatically. No debate. No paperwork. No legal battles. In countries like Germany, biosimilars now make up more than 80% of the market for key drugs in rheumatology and oncology. That’s not a niche. That’s the norm.

The EMA’s approach was simple: focus on science, not extra trials. They didn’t demand new clinical studies just to prove a biosimilar works. Instead, they looked at the data - analytical chemistry, lab tests, animal studies, and a few targeted human trials. If the evidence showed no meaningful difference, the drug got approved. That kept costs down and sped up access.

The United States Started Late - and Got Stuck

The U.S. didn’t even create a legal path for biosimilars until 2009, with the BPCIA law. But even then, the system was tangled. Patent lawsuits, known as the “patent dance,” became a tool for originator companies to delay competition. If a company like AbbVie owned Humira, they’d file dozens of patents - some legitimate, some thin - and drag out court cases for years.

The FDA, meanwhile, demanded more than Europe. For a biosimilar to be labeled “interchangeable” - meaning a pharmacist could swap it for the brand without a doctor’s permission - the agency required switching studies. That meant testing patients who switched back and forth between the brand and the biosimilar. It wasn’t science that demanded this. It was fear. Fear of liability. Fear of confusion. Fear of change.

The result? By 2024, the U.S. had approved only about 20 biosimilars - and only a handful were actually on the market. Compare that to Europe’s 100+. Even when biosimilars were approved, many stayed off shelves because of legal settlements. For example, 14 Humira biosimilars got FDA approval by 2024, but only six were sold because the original manufacturer paid competitors to delay entry.

Costs Are Lower - But Not Everywhere

Biosimilars in Europe launch at a 15% to 30% discount. In the U.S., they often start at the same discount - but then prices drop faster because of competition. Still, the real savings haven’t always reached patients.

In Europe, national health systems negotiate prices centrally. If a biosimilar saves money, the savings go straight into the system. In the U.S., it’s a mess. Hospitals, insurers, pharmacy benefit managers (PBMs), and patients all play different roles. Sometimes, the discount goes to the PBM. Sometimes, the patient still pays a high copay. That’s why, even with biosimilars available, many Americans still pay full price for the brand-name drug.

The Inflation Reduction Act of 2022 changed that for Medicare Part D patients. It capped out-of-pocket costs for insulin and eliminated the coverage gap. For biosimilars, it created financial incentives for insurers to favor them. That’s starting to move the needle.

Regulatory Shifts Are Closing the Gap

In June 2024, the FDA made a major move. They dropped the requirement for switching studies to get “interchangeable” status. That’s huge. It means the U.S. is finally aligning with Europe’s science-based model. No more extra trials just to prove you can switch. If a biosimilar is highly similar, it’s interchangeable.

This isn’t just paperwork. It’s a signal. It tells manufacturers: “We’re serious about competition.” It tells pharmacists: “You can swap these safely.” It tells patients: “You’re not being held back by outdated rules.”

Companies like Pfizer, Merck, and Samsung Bioepis are already rushing to file for interchangeable status. More biosimilars for rheumatoid arthritis, Crohn’s disease, and diabetes are expected to hit the U.S. market by 2026.

Who’s Making These Drugs?

In Europe, Sandoz (a Novartis company), Fresenius Kabi, and Dr. Reddy’s dominate. Germany is a manufacturing hub - not just because of talent, but because the government supports biotech infrastructure. Biosimilar production is a high-tech, high-stakes game. It needs clean rooms, precise temperature controls, and years of process development.

In the U.S., the players are similar but with a twist. Pfizer and Merck have big labs and global reach. Samsung Bioepis, a South Korean company, is now one of the biggest biosimilar suppliers to the U.S. market. Their drugs are made in Asia but approved by the FDA and sold in American hospitals.

The difference? Europe’s companies grew up with the market. U.S. companies had to wait. Now, they’re catching up fast.

Therapeutic Areas: Where the Battle Is Won

In Europe, biosimilars took over autoimmune diseases first. Drugs for rheumatoid arthritis, psoriasis, and inflammatory bowel disease are where savings are biggest. Why? Because millions of people take them. Long-term use = massive costs = big savings.

In the U.S., the early wins were in supportive care. Filgrastim (Zarxio), a drug that helps cancer patients recover white blood cells after chemo, was the first approved biosimilar in 2015. It’s not glamorous. But it’s essential. And it saved hospitals millions.

Now, the U.S. is moving into the same high-value areas as Europe. With Humira’s patents expiring, 14 biosimilars are ready to compete. If even half of them launch, Humira’s market share could drop below 50% in three years.

The Future: Who Leads?

Europe’s biosimilar market was worth $13.16 billion in 2024. The U.S. was at $10.9 billion. But growth rates tell a different story. The U.S. market is projected to grow at 18.5% annually through 2033. Europe’s growth is slower - around 17.3%. Why? Because Europe’s market is already mature. The U.S. is just starting to unlock its potential.

By 2027, North America could overtake Europe in total biosimilar revenue. That’s not because the U.S. is better. It’s because it’s playing catch-up. And with 118 biologics set to lose patent protection between 2025 and 2034, the U.S. has a $232 billion opportunity.

The real winner? Patients. And the healthcare system. Biosimilars are projected to save the U.S. alone over $100 billion by 2030. That’s money that can go to new cancer drugs, mental health services, or lower premiums.

What’s Still Holding Us Back?

Even with progress, challenges remain. Doctors still don’t always trust biosimilars. Some think they’re “second-rate.” Patients worry about switching. Pharmacists need training. Insurance companies still favor brand drugs in their formularies.

Education is the next frontier. Not just for doctors - for patients, nurses, and even insurers. The science is solid. The data is clear. But perception lags.

Manufacturing complexity is another hurdle. Newer biologics - like cell and gene therapies - are harder to copy. Biosimilars for those will take longer. But the first wave is already here.

Bottom Line: Two Paths, One Goal

Europe built a system that worked - early, clear, and science-driven. The U.S. got stuck in legal and bureaucratic weeds. But now, it’s moving fast. The FDA’s 2024 rule change is a turning point. The Inflation Reduction Act is a boost. Patent cliffs are opening up.

The U.S. may not lead in experience - but it’s catching up in speed. And that’s good news for anyone who needs a life-changing drug but can’t afford the price tag.