When it comes to cutting the cost of life-saving biologic drugs, biosimilars are the game-changer. But if you compare how Europe and the United States handle them, you’ll see two very different stories. Europe didn’t just get a head start-it built a system that made biosimilars the default choice. The U.S. started late, got stuck in legal battles, and is now playing catch-up-with momentum building fast.
What Exactly Are Biosimilars?
Biosimilars aren’t generics. You can’t just copy a biologic drug like you would aspirin. Biologics are made from living cells-complex proteins that can vary slightly even between batches made by the same company. A biosimilar is a highly similar version of an already approved biologic, with no meaningful difference in safety, purity, or effectiveness. Think of it like a new recipe for the same cake: same taste, same texture, just made by a different baker.
The first biosimilar ever approved was Omnitrope, a growth hormone, cleared by the European Medicines Agency (EMA) in 2006. That made Europe the pioneer. The U.S. didn’t have a clear path until 2009, when Congress passed the Biologics Price Competition and Innovation Act (BPCIA). But even then, the first U.S. biosimilar, Zarxio (a version of filgrastim), didn’t hit shelves until 2015.
Europe: The Mature Market That Led the Way
By 2024, Europe’s biosimilar market hit $13.16 billion in revenue, according to Precedence Research. That’s not just big-it’s mature. Germany, France, and the UK have been driving adoption for nearly two decades. Hospitals there don’t just accept biosimilars; they actively choose them through tender processes that prioritize cost savings.
One key reason? Regulation. The EMA’s approach is straightforward: prove the biosimilar is highly similar through analytical data, animal studies, and a limited number of clinical trials. No need to repeat massive Phase III trials for every indication. That cuts time and cost, making it easier for companies to enter the market.
And it works. In countries like Germany and Sweden, biosimilars now make up over 80% of the market for certain rheumatology and oncology drugs. Physicians trust them. Pharmacists swap them out without hesitation. Patients don’t even notice the change.
Europe also has a strong manufacturing base. Companies like Sandoz (Novartis), Fresenius Kabi, and Amgen have built major production facilities there. Germany, in particular, has become a hub-not just for selling biosimilars, but for making them at scale.
The United States: Late Start, Big Catch-Up
The U.S. market was slower to grow-not because biosimilars didn’t work, but because they were blocked. Originator drugmakers used patent thickets, legal maneuvers, and the so-called “patent dance” under the BPCIA to delay competition. Even when a biosimilar got FDA approval, it couldn’t launch because of lawsuits.
By 2024, Europe had approved over 100 biosimilars since 2006. The U.S. had approved just 20. And only a fraction of those were actually on the market. Take Humira, the best-selling drug in history. In 2024, 14 biosimilars were approved in the U.S.-but only six were available because of patent settlements that delayed entry.
What changed? Two things: money and regulation.
The Inflation Reduction Act of 2022 removed the Medicare Part D coverage gap-the “donut hole”-which made biosimilars more attractive to insurers and patients. Suddenly, saving $10,000 per patient per year on a biologic drug meant real savings for Medicare.
Then, in June 2024, the FDA dropped a major rule: no more switching studies to get “interchangeable” status. Before, companies had to prove patients could switch back and forth between the biosimilar and the original without any safety issues. That meant expensive, lengthy trials. Now, the FDA says: if you’ve shown similarity through analytical and clinical data, you’re eligible. That’s the same standard Europe has used for years.
Market Size and Growth: Who’s Winning?
In 2024, the U.S. biosimilar market was worth $10.9 billion, according to Alira Health. Europe’s was $13.16 billion. So Europe still leads in revenue.
But growth? That’s where the U.S. is pulling ahead. The U.S. market is projected to grow at an 18.5% CAGR through 2033, hitting $30.2 billion. Europe’s growth is strong too-17.34% CAGR-but it’s starting from a higher base. North America as a whole is expected to overtake Europe in market size by 2027, according to Grand View Research.
Why? The U.S. has a massive pipeline of expiring patents. IQVIA estimates 118 biologics will lose exclusivity between 2025 and 2034. That’s a $232 billion opportunity. Humira’s biosimilars are just the beginning. Drugs like Enbrel, Remicade, and Rituxan are next in line.
Therapeutic Areas: Where Biosimilars Are Making the Biggest Impact
Europe led with autoimmune diseases-rheumatoid arthritis, Crohn’s disease, psoriasis. Biosimilars for drugs like adalimumab and infliximab became the standard of care. Oncology followed closely.
The U.S. started with supportive care: filgrastim (for white blood cell counts after chemo) and epoetin (for anemia). These were simpler to develop and less controversial. But now, the U.S. is moving into the same complex areas as Europe. By 2025, biosimilars for trastuzumab (Herceptin) and bevacizumab (Avastin) are gaining traction in cancer care.
The real win? Cost savings. Biosimilars typically launch at 15-30% below the reference drug. In Europe, that’s translated to billions saved in public health budgets. In the U.S., it’s starting to add up too. A single biosimilar for Humira could save Medicare $2 billion over five years.
Who’s Making Them? Key Players in Each Market
In Europe, Sandoz, Fresenius Kabi, and Amgen dominate. These companies have decades of experience in biologics manufacturing and regulatory navigation.
In the U.S., Pfizer, Merck, and Samsung Bioepis are leading the charge. Pfizer’s biosimilar for Humira, Amsa, launched in 2023 and quickly gained market share. Samsung Bioepis, a South Korean company, has partnered with Merck to bring multiple biosimilars to the U.S. market.
One thing to note: many of the same companies operate in both markets. But the U.S. market is more competitive because of the size of the prize. More players mean more pressure to price aggressively.
The Road Ahead: Convergence, Not Competition
Europe and the U.S. aren’t rivals anymore-they’re learning from each other. The FDA’s 2024 rule change mirrors Europe’s approach. Europe, meanwhile, is watching how the U.S. handles pricing negotiations and payer contracts.
Manufacturing is becoming more global. A biosimilar made in Ireland might be sold in Texas. Clinical data from a U.S. trial might be used to support approval in Germany.
The biggest challenge now? Education. Many doctors still think biosimilars are “lesser.” Patients worry about switching. Payers need better tools to track savings. But the data is clear: biosimilars are safe, effective, and affordable.
By 2030, biosimilars could save the U.S. healthcare system over $100 billion. In Europe, that number will be even higher. The goal isn’t to replace biologics-it’s to make them accessible to everyone who needs them.
Are biosimilars the same as generics?
No. Generics are exact chemical copies of small-molecule drugs like aspirin or metformin. Biosimilars are highly similar to complex biologic drugs made from living cells. They’re not identical, but they work the same way with no meaningful difference in safety or effectiveness. The FDA and EMA require extensive testing to prove this similarity.
Why did Europe adopt biosimilars faster than the U.S.?
Europe created a clear regulatory pathway in 2006 and encouraged adoption through hospital tenders, mandatory substitution policies, and strong communication with doctors. The U.S. had a delayed regulatory start, faced aggressive patent litigation from originator companies, and lacked coordinated payer incentives until recently. The FDA’s 2024 rule change on interchangeability is now helping close that gap.
Can a pharmacist switch my biologic to a biosimilar without asking me?
In Europe, yes-in many countries, substitution is automatic unless the doctor specifies otherwise. In the U.S., it depends. Only biosimilars designated as “interchangeable” by the FDA can be substituted without the prescriber’s permission. As of 2025, only a few biosimilars have this status, but more are expected after the FDA’s 2024 guidance change.
How much money do biosimilars actually save?
Biosimilars typically launch at 15% to 30% lower than the original biologic. In some cases, after competition increases, prices drop by 50% or more. For example, Humira biosimilars in the U.S. are priced 40-50% below the original. Over five years, this could save Medicare over $2 billion per drug. In Europe, biosimilars have saved health systems tens of billions since 2006.
What’s stopping biosimilars from growing even faster?
Manufacturing complexity remains a barrier-biologics are harder to make than pills. Patent litigation still happens, especially in the U.S. There’s also lingering skepticism among some doctors and patients, despite strong safety data. And payer systems need better tools to track and incentivize biosimilar use. But these barriers are shrinking fast as evidence piles up.