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.
Are biosimilars the same as generics?
No. Generics are exact chemical copies of small-molecule drugs like aspirin or metformin. Biosimilars are copies of large, complex biologic drugs made from living cells-like antibodies or proteins. They’re highly similar, but not identical. Even tiny changes in manufacturing can affect their structure. That’s why they require more testing than generics.
Why are biosimilars cheaper than the original biologics?
Biologics cost billions to develop and can take over a decade to bring to market. Biosimilar manufacturers don’t have to repeat all the expensive clinical trials because they prove similarity to an already-approved drug. They focus on analytical data and targeted studies. That cuts development time and cost by 50-70%, allowing them to offer lower prices-typically 15-50% less than the brand.
Can a pharmacist switch me to a biosimilar without asking my doctor?
It depends on the state and whether the biosimilar is designated as "interchangeable" by the FDA. In Europe, substitution is often automatic. In the U.S., only interchangeable biosimilars can be substituted without the prescriber’s permission. As of 2025, only a few U.S. biosimilars have that status-but more are expected after the FDA’s 2024 guidance change.
Why did it take the U.S. so long to approve biosimilars?
The U.S. didn’t lack the science-it lacked the will. The BPCIA created legal barriers, including patent litigation tactics by brand-name companies. The FDA also required extra clinical trials (switching studies) that weren’t scientifically necessary. These hurdles delayed approvals and discouraged manufacturers from entering the market. It wasn’t until 2024 that the FDA removed the switching study requirement, aligning more closely with Europe’s approach.
What’s the biggest barrier to biosimilar adoption today?
Lack of awareness and trust. Many doctors and patients still think biosimilars are "second-rate" or less safe. Education is the biggest gap. Even though studies show biosimilars work just as well, patients may refuse to switch. Payers need to lead with incentives, and providers need clear guidance to reassure patients.
Will biosimilars replace all biologics eventually?
Not all-but most high-cost ones will. Biologics for autoimmune diseases, cancer, and diabetes are prime targets. As patents expire, biosimilars will capture 60-80% of the market in those areas, just like they did in Europe. But for newer, more complex biologics-like gene therapies-biosimilars may take longer to develop. The goal isn’t replacement-it’s competition to drive down prices and increase access.
Andrew Forthmuller
November 13, 2025 AT 05:40U.S. biosimilars are still stuck in 2012 while Europe’s moving to 2025. Just sayin’.
Danae Miley
November 13, 2025 AT 07:58Let’s be clear: the FDA’s switching study requirement was never science-it was regulatory theater designed to appease Big Pharma. Removing it in 2024 was the first honest move the U.S. has made in this space. Europe didn’t need it. We did. And now we’re catching up. Not because we’re smarter, but because we finally stopped overcomplicating things.
Charles Lewis
November 14, 2025 AT 00:59It is worth noting, with a degree of academic rigor and historical context, that the structural divergence between the European and American biosimilar markets is not merely a function of regulatory design, but rather a reflection of deeper cultural and institutional norms regarding healthcare delivery, physician autonomy, and payer influence. In Europe, centralized procurement systems and strong public health mandates have enabled coordinated adoption; in the United States, a fragmented, profit-driven ecosystem has incentivized delay, obfuscation, and legal maneuvering. The fact that we are now seeing accelerated growth is less a triumph of policy and more a consequence of inevitable market pressure-patents expire, costs rise, and patients demand affordability. The real question is whether this momentum will be sustained beyond the temporary legislative tailwinds of the Inflation Reduction Act.
Renee Ruth
November 14, 2025 AT 03:12They’re all just waiting for Humira’s biosimilars to blow up. And when they do? Everyone’s gonna pretend they saw it coming. But no one lifted a finger until AbbVie’s monopoly started crumbling. Now it’s ‘oh wow, biosimilars are great!’ Funny how that works. Meanwhile, real patients have been paying $2k/month for 15 years while lawyers got rich.
Samantha Wade
November 14, 2025 AT 23:35The U.S. isn’t just catching up-it’s redefining the race. The FDA’s 2024 guidance change didn’t just align us with Europe; it removed a decades-old barrier that was never scientifically justified. Combine that with the Inflation Reduction Act’s cost caps and Medicare incentives, and you’ve got a perfect storm for adoption. This isn’t just about savings-it’s about access. Imagine a diabetic who can now afford insulin because a biosimilar dropped the price by 60%. That’s not policy. That’s humanity. And we’re finally building a system that reflects it. The manufacturing capacity is coming. The education is lagging, but it’s starting. This is the moment we turn the corner.
Elizabeth Buján
November 15, 2025 AT 05:57bro honestly i just want my mom to be able to afford her rheumatoid arthritis meds without selling her jewelry. biosimilars sound like magic if they work the same and cost less. why are we still arguing about this? doctors dont get it, patients are scared, and the system is just… broken. but if we can fix it, we should. i believe in it.
vanessa k
November 16, 2025 AT 09:37It’s not that Americans don’t trust biosimilars-it’s that we’ve been lied to for so long. The pharma ads scream ‘brand name = safety’ while the biosimilar gets buried under paperwork and legal threats. No wonder people are hesitant. But the data doesn’t lie. The science is solid. We just need to stop treating patients like lab rats and start treating them like people who need help. Education isn’t optional anymore. It’s the last mile.
manish kumar
November 16, 2025 AT 10:54India’s biosimilar industry is already a global powerhouse-we produce over 40% of the world’s generic biologics. Companies like Biocon and Dr. Reddy’s have been exporting to Europe and the U.S. for over a decade. The real story isn’t just Europe vs. U.S.-it’s how the Global South quietly built the infrastructure that makes these drugs affordable. The U.S. is finally waking up, but the real innovation and manufacturing capacity came from places nobody talks about. Let’s not forget who actually made this possible.
Nicole M
November 18, 2025 AT 08:55so wait-pharmacists can’t swap biosimilars unless the FDA says it’s ‘interchangeable’? but in europe they just do it? that’s wild. why are we still making this so hard? i’m not a doctor but even i get that if it’s the same, just swap it. why do we need 10 more studies?
Arpita Shukla
November 18, 2025 AT 16:22You’re all missing the point. Biosimilars aren’t the solution-they’re a distraction. The real problem is that biologics were overpriced from day one because the FDA allowed patent evergreening and data exclusivity to be weaponized. We didn’t need biosimilars-we needed price controls. Now we’re celebrating a workaround instead of fixing the root cause. And don’t get me started on how ‘interchangeable’ is just a marketing label that doesn’t mean anything clinically. It’s all theater.
Benjamin Stöffler
November 20, 2025 AT 05:48Let’s be brutally honest: the U.S. healthcare system doesn’t want biosimilars to succeed. It wants to maintain the illusion of innovation while extracting maximum profit. The patent dance? It’s not a legal process-it’s a racket. The switching studies? A bureaucratic smokescreen. The FDA’s 2024 change? A reluctant concession, not a visionary move. And yet, here we are, applauding ourselves for doing the bare minimum. We’re not catching up to Europe-we’re finally stopping sabotaging ourselves. But let’s not pretend this is progress. It’s damage control.
Mark Rutkowski
November 21, 2025 AT 22:18There’s a quiet revolution happening-not in boardrooms or patent courts, but in the quiet moments between a doctor and a patient who can finally breathe because their insulin isn’t a luxury. Biosimilars aren’t just cheaper drugs-they’re the quiet echo of a promise we forgot: that medicine should heal, not bankrupt. Europe built the roadmap. The U.S. is finally walking it. Not because we’re better, but because we had no choice. And maybe, just maybe, this is how systems change-not with fanfare, but with necessity.
Ryan Everhart
November 22, 2025 AT 12:32So Europe spent 20 years building a system that works. The U.S. spent 20 years suing people and making them do extra tests. Now we’re ‘catching up.’ Congrats. I’m sure the lawyers who made billions off delays are thrilled with the new ‘efficiency.’