When you hear the word biosimilar, you might think it’s just another generic drug. But it’s not. Biosimilars aren’t copies like the little pills you pick up at the pharmacy. They’re complex, living medicines made from living cells - think of them as near-identical twins to expensive biologic drugs used for cancer, rheumatoid arthritis, and diabetes. And while they’ve been saving patients money for nearly two decades in Europe, the United States is only now catching up - and fast.
Europe Led the Way - and Built a System That Works
Europe didn’t wait for permission. In 2006, the European Medicines Agency (EMA) approved the first biosimilar ever: Omnitrope, a version of the growth hormone somatropin. That wasn’t a lucky accident. It was the result of a deliberate, science-backed regulatory framework designed to make biosimilars accessible without sacrificing safety. The EMA didn’t demand endless new clinical trials. Instead, they looked at the totality of evidence - detailed molecular analysis, lab tests, and a few targeted studies - to prove a biosimilar was as safe and effective as the original.
That clarity changed everything. Hospitals in Germany, France, and the UK started using biosimilars in their tenders. Payers pushed for them. Doctors got used to them. Patients didn’t even notice the switch. By 2024, Europe’s biosimilar market hit $13.16 billion in revenue, with oncology and autoimmune disease treatments like adalimumab and infliximab seeing over 80% market share in some countries. Germany became a manufacturing hub, drawing global companies because the rules were clear, the path was open, and the system rewarded cost savings.
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 just to approve the first biosimilar: Zarxio, a version of filgrastim, in 2015. Why the delay? Patent lawsuits. Big pharma companies used legal tactics - known as the “patent dance” - to delay competition. They filed dozens of suits, creating a minefield for any company trying to enter the market. Even when a biosimilar got FDA approval, it couldn’t always reach patients because of complex reimbursement rules and lack of payer incentives.
By 2024, the U.S. had only approved around 20 biosimilars - compared to over 100 in Europe since 2006. And while Europe had biosimilars dominating key therapies, the U.S. mostly stuck to simpler, lower-cost products like filgrastim. Complex drugs like Humira (adalimumab), which cost over $20,000 a year per patient, stayed out of reach for years because of legal battles. Even when 14 Humira biosimilars were approved in 2024, only six were actually on the market due to patent settlements.
The Turning Point: FDA Changes the Rules
In June 2024, everything shifted. The FDA proposed new guidelines that eliminated the requirement for switching studies to get an “interchangeable” designation. That’s a big deal. Before, companies had to prove that patients could switch back and forth between the biosimilar and the original drug without any safety risk - a requirement that didn’t exist in Europe and added years to development timelines.
That change wasn’t just bureaucratic. It was strategic. It aligned the U.S. more closely with Europe’s science-first approach. Suddenly, companies could bring biosimilars to market faster, cheaper, and with less risk. The FDA recognized what Europe had known for years: if a biosimilar meets the same high standards for quality and safety, switching doesn’t need to be proven - it’s implied.
Why the U.S. Is Now Playing Catch-Up - and Winning
Despite starting behind, the U.S. has massive momentum. The Inflation Reduction Act of 2022 removed the Medicare Part D coverage gap - the infamous “donut hole” - and gave insurers a financial incentive to choose biosimilars. That meant hospitals and pharmacies could save millions without hurting patient access.
Plus, the U.S. has more high-value biologics coming off patent. Between 2025 and 2034, 118 biologics will lose exclusivity, creating a $232 billion opportunity. Humira’s biosimilars are just the beginning. Drugs like Enbrel, Rituxan, and Herceptin are next in line. By 2033, the U.S. biosimilar market is projected to hit $30.2 billion, growing at an 18.5% annual rate - faster than Europe’s projected 17.34%.
North America as a whole is expected to overtake Europe in market size by 2027. That’s not because Europe is slowing down - it’s because the U.S. is accelerating. The pieces are finally falling into place: better regulation, stronger financial incentives, and a flood of new biosimilars ready to enter the market.
Who’s Making These Drugs - And Where?
In Europe, companies like Sandoz (Novartis), Fresenius Kabi, and Amgen dominate. They’ve built deep expertise in manufacturing complex biologics and have strong relationships with national health systems. In the U.S., Pfizer, Merck, and Samsung Bioepis are leading the charge. But the real story isn’t just who’s making them - it’s where they’re made. Germany remains the biosimilar manufacturing powerhouse, with advanced facilities and skilled labor. But U.S. companies are now investing heavily in domestic production, partly to avoid supply chain risks and partly to meet growing demand.
What’s Next? The Road Ahead
The biggest challenge now isn’t regulation - it’s education. Many doctors still don’t fully understand biosimilars. Some patients are wary of switching from a drug they’ve been on for years. That’s why clear communication from health systems, pharmacists, and insurers is critical. The data is solid: biosimilars are safe. They work. And they save money - often 15% to 30% less than the original biologic.
Looking ahead, both markets will face new hurdles. Next-generation biologics - like bispecific antibodies and cell therapies - are even harder to copy. Regulatory agencies will need to adapt. But the lesson from Europe is clear: if you build a transparent, science-based system, adoption follows. The U.S. is learning that lesson quickly.
By 2034, the global biosimilar market could hit $176 billion. Europe will still be a major player. But the U.S. is no longer the slow follower. It’s becoming the fastest-growing market in the world - and the one with the most to gain.
What’s the difference between a biosimilar and a generic drug?
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 - like antibodies or proteins. You can’t copy them exactly, so they’re called “biosimilar,” not “generic.” They must prove no clinically meaningful difference in safety or effectiveness, but they’re not identical.
Why are biosimilars cheaper than the original biologics?
Developing a biologic drug costs billions and takes over a decade. Biosimilar manufacturers don’t have to repeat all the early research - they use the original drug’s data to prove similarity. That cuts development time and cost by 50% or more. They still need rigorous testing, but they avoid the massive upfront R&D expenses, which lets them price lower.
Are biosimilars safe to use?
Yes. The EMA and FDA require the same high standards for safety, purity, and potency as the original biologic. Over 100 biosimilars have been used in Europe since 2006 with no new safety concerns. In the U.S., approved biosimilars have been used in millions of patient-years with outcomes matching the reference product.
Why did Europe adopt biosimilars faster than the U.S.?
Europe created a clear, unified regulatory path early on. Hospitals used competitive tenders to choose biosimilars, and governments encouraged substitution. In the U.S., patent lawsuits, fragmented payer systems, and strict interchangeability rules slowed things down. The U.S. is now catching up because it’s removing those barriers - especially after the FDA dropped the switching study requirement in 2024.
Which countries in Europe lead in biosimilar use?
Germany, France, and the United Kingdom lead in adoption. Germany is also the top manufacturing hub, with companies like Sandoz and Fresenius Kabi operating major production sites. These countries have strong public health systems that prioritize cost savings and have clear policies encouraging biosimilar use in hospitals and clinics.
What’s the biggest barrier to biosimilar adoption in the U.S. today?
The biggest barrier now is physician and patient awareness. Even with better regulation and lower prices, many doctors still prescribe the original biologic out of habit. Patients may be hesitant to switch. Education campaigns by insurers, pharmacists, and medical societies are now critical to closing that gap.
Will biosimilars replace biologics completely?
No - but they’ll take over the majority of the market. Biologics will still be used for patients who don’t respond to biosimilars or have rare conditions. But for most patients, biosimilars will become the standard first choice because they’re just as effective and much cheaper. In some European countries, biosimilars already make up 80% to 90% of new prescriptions for certain drugs.
Nikolai Mortenson
Hello, my name is Nikolai Mortenson, and I am a dedicated expert in the field of pharmaceuticals. I have spent years studying and researching various medications and their effects on the human body. My passion for understanding diseases and their treatments has led me to become a prolific writer on these topics. I aim to educate and inform people about the importance of proper medication usage, as well as the latest advancements in medical research. I often discuss dietary supplements and their role in health maintenance. Through my work, I hope to contribute to a healthier and more informed society. My wife Abigail and our two children, Felix and Mabel, are my biggest supporters. In my free time, I enjoy gardening, hiking and, of course, writing. Our Golden Retriever, Oscar, usually keeps me company during these activities. I reside in the beautiful city of Melbourne, Australia.
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