Biosimilars are not generics. While generics are exact copies of small-molecule drugs, biosimilars are highly similar versions of complex biologic medicines-proteins made from living cells. These drugs treat serious conditions like cancer, rheumatoid arthritis, and diabetes. But when it comes to how they’re adopted, Europe and the United States are playing two very different games.
Europe Led the Way-And Never Looked Back
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 set the tone. By 2024, Europe’s biosimilar market hit $13.16 billion in revenue, according to Precedence Research. Germany, France, and the UK became leaders in adoption, not because of luck, but because of clear rules.European hospitals used centralized tenders to pick the cheapest option. Payers pushed for biosimilars because they saved money-often 15% to 30% less than the original biologic. Doctors trusted them. Patients accepted them. By 2024, in some countries, biosimilars made up over 80% of the market for key drugs like adalimumab and infliximab in rheumatology and oncology.
The EMA’s approach was simple: prove the biosimilar is highly similar through detailed lab tests, animal studies, and a few targeted clinical trials. No need for massive, expensive studies on every patient group. That kept development faster and cheaper. And because the EMA approved the drug for the whole EU, manufacturers could launch across 27 countries with one application.
The U.S. Started Late-And Got Stuck
The United States passed the Biologics Price Competition and Innovation Act (BPCIA) in 2009, but it took six years before the first biosimilar, Zarxio, was approved in 2015. Why the delay? Legal battles.Originator companies used patent thickets-layers of overlapping patents-to block competition. They dragged biosimilar makers into court for years. Even when a biosimilar got FDA approval, it couldn’t reach patients because of patent settlements. As of 2024, the U.S. had approved over 20 biosimilars, but only 12 were actually on the market. Compare that to Europe, where more than 100 biosimilars have been approved since 2006.
Another hurdle? Interchangeability. The FDA required biosimilar makers to prove that switching between the original drug and the biosimilar didn’t increase risk. That meant extra clinical trials-switching studies-that added cost and time. Most companies didn’t bother. Only a handful of biosimilars in the U.S. had interchangeable status.
On top of that, the U.S. healthcare system is a maze. FDA approves the drug, but then Medicare, private insurers, pharmacy benefit managers, and hospitals each make their own decisions. No unified push for cost savings. Doctors weren’t always educated on biosimilars. Patients were skeptical.
2024 Was the Turning Point for the U.S.
Everything changed in June 2024. The FDA dropped the requirement for switching studies to get interchangeable status. That was huge. Suddenly, the U.S. regulatory path looked a lot more like Europe’s.Why does this matter? Interchangeable biosimilars can be substituted at the pharmacy without a doctor’s approval-just like generics. That’s the key to mass adoption. Before this change, only one biosimilar had interchangeable status in the U.S. Now, companies are rushing to submit applications. Pfizer, Merck, and Samsung Bioepis are all preparing to launch more interchangeable versions.
The Inflation Reduction Act of 2022 also helped. It closed the Medicare Part D coverage gap, meaning seniors pay less out of pocket for expensive drugs. That made biosimilars more attractive to both patients and insurers. In 2024, the U.S. biosimilar market hit $10.9 billion-up from $7.1 billion in 2020. Projections show it could hit $30 billion by 2033.
Market Size: Europe Still Leads, But the U.S. Is Catching Fast
As of 2024, Europe’s biosimilar market is bigger: $13.16 billion versus the U.S.’s $10.9 billion. But growth rates tell a different story. Europe’s market is growing at about 17.3% per year. The U.S. is growing at 18.5%-faster.Why? The U.S. is catching up. It has a much larger pool of high-revenue biologics coming off patent. Between 2025 and 2034, 118 biologics will lose exclusivity-worth $232 billion in sales, according to IQVIA. Humira alone, a top-selling drug for autoimmune diseases, had 14 biosimilars approved in the U.S. by 2024. That’s more than any other drug in history.
By 2027, North America (mostly the U.S.) is expected to overtake Europe as the largest biosimilar market. Grand View Research predicts North America will reach $17.2 billion by then, while Europe will still grow-but slower. Europe’s market is already mature. The U.S. has a lot of room to grow.
Who’s Making These Drugs?
In Europe, Sandoz (a Novartis company), Fresenius Kabi, and Amgen dominate. These companies built their biosimilar businesses over 15 years. They’re experts in manufacturing complex proteins.In the U.S., Pfizer, Merck, and Samsung Bioepis are leading the charge. Pfizer’s adalimumab biosimilar, Amjevita, became one of the first to gain interchangeable status after the 2024 rule change. Samsung Bioepis, originally from South Korea, has become a global player with products approved in both markets.
Germany is still the biosimilar manufacturing hub. Its strong pharmaceutical infrastructure and skilled workforce attract global companies. Many U.S. firms partner with German manufacturers to produce their biosimilars.
Therapeutic Areas: Where Biosimilars Are Winning
In Europe, biosimilars are most common in autoimmune diseases: rheumatoid arthritis, Crohn’s disease, psoriasis. Drugs like adalimumab, infliximab, and etanercept are now mostly biosimilars in many hospitals.The U.S. started slower. Early wins were in supportive care-like filgrastim, which helps cancer patients recover white blood cells after chemotherapy. But now, the focus is shifting. With Humira’s patent cliff, oncology and immunology are exploding. By 2026, biosimilars for drugs like rituximab, bevacizumab, and trastuzumab could be standard in U.S. cancer centers.
The Road Ahead: Convergence, Not Competition
Europe and the U.S. are moving toward the same goal: more affordable biologics. The U.S. is copying Europe’s playbook-simpler approval rules, faster interchangeability, payer incentives. Europe is watching the U.S. scale up and wondering how to keep its lead.Manufacturing complexity is the next challenge. Newer biologics-like bispecific antibodies and cell therapies-are harder to copy. Only a few companies have the tech and expertise. Both regions will need to invest in next-generation production.
Education still matters. Many doctors still think biosimilars are "inferior." Patients worry about switching. Clear communication from regulators, medical societies, and patient groups will be key.
By 2034, the global biosimilar market could hit $176 billion. Europe and the U.S. will together account for more than half of that. The difference? Europe built its foundation early. The U.S. is now building fast-and with more money at stake.
One thing is clear: biosimilars aren’t the future. They’re here. And whether you’re in London or Los Angeles, you’ll be using them soon.
Are biosimilars the same as generics?
No. Generics are exact chemical copies of small-molecule drugs, like aspirin or metformin. Biosimilars are highly similar versions of complex biologic drugs made from living cells-like antibodies or proteins. They can’t be identical, but they must have no clinically meaningful differences in safety or effectiveness. That’s why they require more testing than generics.
Why are biosimilars cheaper than the original biologics?
Because they don’t need to repeat the full clinical trials the original drug went through. Biosimilar makers use data from the reference product and only run targeted studies to prove similarity. That cuts development costs by 50-70%. Also, competition among multiple biosimilar makers drives prices down further.
Can a pharmacist substitute a biosimilar without asking the doctor?
Only if the biosimilar has "interchangeable" status. In Europe, substitution rules vary by country-some allow it automatically, others require doctor approval. In the U.S., only interchangeable biosimilars can be substituted without the prescriber’s consent. After the FDA’s June 2024 rule change, more biosimilars are expected to gain this status, making substitution easier.
Which countries in Europe lead in biosimilar use?
Germany, France, and the United Kingdom are the top adopters. Germany leads in manufacturing and has the most aggressive hospital procurement policies. France and the UK have strong national health systems that prioritize cost savings, making biosimilars the default choice in many cases.
What’s holding back biosimilar adoption in the U.S.?
Three main things: patent lawsuits, lack of interchangeability, and a fragmented healthcare system. Originator companies used legal tactics to delay entry. The FDA’s old switching study requirement made it hard to get interchangeable status. And with no central authority pushing biosimilars, insurers and pharmacies often didn’t prioritize them.
Will biosimilars replace original biologics completely?
Not completely, but they’ll become the standard. In Europe, some biologics now have over 80% biosimilar use. In the U.S., that’s coming fast-especially for drugs like Humira. Original manufacturers will still have a share, especially for newer versions or combination therapies. But cost pressure will make biosimilars the first choice for most patients and providers.
How do biosimilars impact healthcare costs?
Significantly. In Europe, biosimilars have saved health systems over $10 billion since 2006. In the U.S., a single biosimilar for Humira could save Medicare $25 billion over 10 years. As more biologics lose patent protection, biosimilars will drive the biggest cost reductions in healthcare in decades.
Are biosimilars safe?
Yes. Both the EMA and FDA require biosimilars to meet the same high standards for safety, purity, and potency as the original biologic. Millions of patients worldwide have used biosimilars for over 15 years with no new safety concerns. Regulatory agencies continue to monitor them closely after approval.