Biologic drugs like Humira, Enbrel, and Keytruda have saved lives, but they’ve also cost patients and insurers hundreds of billions of dollars. Why? Because even after the original patents expire, biosimilars-cheaper, highly similar versions-can’t enter the market for up to 12 years. That’s not a typo. It’s the law.
How Long Do Biologics Get Protected?
In the U.S., the Biologics Price Competition and Innovation Act (BPCIA) of 2009 gives innovator companies a 12-year period of market exclusivity. This isn’t just about patents. It’s a legal shield. For the first four years after a biologic gets FDA approval, no one can even submit an application for a biosimilar. For the next eight years, applications can be filed-but the FDA can’t approve them until the full 12 years are up. That’s two layers of protection: one for data, one for market access.
This clock starts ticking on the day the original drug is licensed by the FDA. If the manufacturer adds a pediatric study, the clock can stretch to 12.5 years. Compare that to Europe, where biologics get 10 years of data exclusivity plus one year of market exclusivity-11 total. Or Japan, which offers 8 years of data protection and 4 of market exclusivity. The U.S. system is the longest in the developed world.
Why Don’t Biosimilars Show Up Right Away?
Even when the 12-year clock runs out, biosimilars still don’t flood the market. Why? Because of the patent dance.
This isn’t a dance you’d see at a wedding. It’s a legal process baked into the BPCIA. When a company wants to make a biosimilar, it must share its entire application and manufacturing details with the original drugmaker within 20 days of FDA acceptance. The original company then has 60 days to list every patent it thinks might be infringed. The biosimilar maker responds with legal arguments for why those patents don’t apply. Then both sides enter a 15-day negotiation to pick which patents to fight over in court.
It sounds fair. But in practice, it’s a delay tactic. Companies like AbbVie have filed over 160 patents on Humira-many covering minor changes in delivery devices or dosing schedules, not the actual drug. These aren’t real innovations. They’re legal fences. Courts take years to sort through them. By the time a biosimilar wins, the original drugmaker has already extended its grip through new formulations, combo therapies, or rebates to insurers.
Humira’s 12-Year Lockdown
Humira (adalimumab) is the poster child for how this system works-and how it fails patients.
It was approved in 2002. Its core patent expired in 2016. But because of the BPCIA’s 12-year exclusivity, the first U.S. biosimilar didn’t launch until December 2023-over 21 years after approval. Meanwhile, in Europe, biosimilars hit the market in 2018. European patients paid 70% less. In the U.S., Humira’s price jumped 470% between 2012 and 2022. Patients skipped doses. Some stopped treatment entirely. The Arthritis Foundation found that 63% of pharmacists had patients who abandoned biologics because of cost.
That’s not just expensive. It’s dangerous.
It’s Not Just About Patents-It’s About Cost
Developing a biosimilar isn’t like making a generic pill. You can’t just reverse-engineer the formula. Biologics are made from living cells-mammalian, yeast, or bacterial. Tiny changes in temperature, pH, or fermentation time alter the final product. That’s why biosimilar makers must prove their drug is highly similar with no clinically meaningful differences in safety, purity, and potency.
This requires expensive testing: analytical studies, animal trials, pharmacokinetic studies, and sometimes full clinical trials. Pfizer says it costs over $100 million and takes 5 to 9 years. For complex biologics like antibody-drug conjugates or cell therapies, costs can hit $250 million.
Compare that to a small-molecule generic: $1-$2 million and two years to develop. That’s why only 38 biosimilars have been approved in the U.S. since 2015. In Europe, it’s 88.
The Biosimilar Void: 118 Drugs, Only 12 in Development
Between 2025 and 2034, 118 biologics will lose exclusivity. Together, they represent a $234 billion market. But only 12 of them have biosimilars in development.
Why the gap? Three big reasons:
- Patent thickets scare off developers. If a company spends $150 million and then gets sued for 5 years, the return isn’t worth it.
- Orphan drugs-medicines for rare diseases-make up 64% of expiring biologics. Small patient pools mean lower sales potential. Only one orphan biologic, eculizumab, has a biosimilar in the pipeline.
- Complex molecules like bispecific antibodies and gene therapies are technically daunting. None currently have biosimilars in development, even though 16 will lose protection by 2034.
This is the biosimilar void. A gap between what’s possible and what’s happening. And it’s getting wider.
Who’s Winning? Who’s Losing?
The innovator companies win. They keep prices high. They extend monopolies. They settle lawsuits with biosimilar makers to delay entry-what critics call pay-for-delay.
Patients lose. They pay 300% more than Europeans for the same drug. Some skip doses. Some die.
Pharmacists lose. They can’t offer cheaper alternatives. They watch patients struggle.
Even the healthcare system loses. The Congressional Budget Office estimated that if biosimilars entered faster, the U.S. could save $158 billion over the next decade. Under current rules? Just $71 billion.
What’s Being Done?
The FDA has tried. Its 2022 Biosimilars Action Plan promised better communication, faster reviews, and more market support. But progress is slow. Only 38 biosimilars approved in 10 years. That’s less than four per year.
Legislation has stalled. The Biosimilars User Fee Act of 2022 aimed to speed up approvals but died in committee. Congress hasn’t touched the 12-year exclusivity rule since 2010.
Meanwhile, the European Union has pushed adoption. Once skeptical, doctors and insurers now accept biosimilars. Today, 72% of biologics in Europe are biosimilars. That’s not luck. It’s policy: mandatory substitution, education campaigns, and price pressure.
The U.S. could do the same. But it won’t unless the rules change.
What’s Next?
By 2026, more than 20 biologics will be eligible for biosimilar entry. If the system stays the same, most will still be blocked by lawsuits, patent thickets, or corporate strategy. But if Congress shortens exclusivity, if the FDA pushes faster approvals, if insurers demand biosimilars-change is possible.
The science is ready. The cost savings are real. The patients are waiting.
How long must a biologic be on the market before a biosimilar can be approved in the U.S.?
A biosimilar cannot be approved by the FDA until 12 years after the original biologic received its first license. This is mandated by the Biologics Price Competition and Innovation Act (BPCIA). Even though biosimilar manufacturers can submit applications after 4 years, the FDA is legally barred from approving them until the full 12-year period ends.
Why are biosimilars more expensive to develop than generic drugs?
Biosimilars are made from living cells, not chemicals. Their structure is far more complex than small-molecule generics. To prove they’re highly similar, manufacturers must run expensive analytical tests, animal studies, and sometimes clinical trials. Development takes 5-9 years and costs over $100 million-up to $250 million for complex therapies. Generic drugs, by contrast, cost $1-$2 million and take about two years.
What is the "patent dance" and how does it delay biosimilars?
The "patent dance" is a legal process under the BPCIA where biosimilar applicants must share their application with the original drugmaker, who then lists patents it believes are infringed. The biosimilar maker responds with legal arguments, and both sides negotiate which patents to litigate. This process can drag on for years. Companies often file dozens of weak patents to create legal noise, forcing biosimilar makers into costly lawsuits that delay market entry.
Why are so few biosimilars being developed for orphan drugs?
Orphan drugs treat rare diseases with small patient populations, making the potential return on investment low. Developing a biosimilar costs over $100 million, and if only a few thousand patients use the drug, the company can’t recoup its costs. As a result, 88% of expiring biologics with orphan indications have no biosimilars in development, even though they’re often the most expensive treatments.
How does the U.S. compare to Europe on biosimilar access?
Europe grants 10 years of data exclusivity plus 1 year of market exclusivity-11 total-compared to the U.S.’s 12 years. Europe also has stronger policies encouraging biosimilar use: doctors are trained to prescribe them, insurers favor lower-cost options, and substitution is allowed. As a result, biosimilars make up 72% of the biologics market in Europe. In the U.S., they’re under 10%, despite having the same approved products.
What’s the biggest barrier to faster biosimilar entry in the U.S.?
The biggest barrier is the combination of 12-year exclusivity and patent thickets. Even after the 12 years are up, innovator companies use hundreds of low-quality patents to launch lawsuits that delay biosimilar approval for years. This legal uncertainty makes it too risky and expensive for manufacturers to enter the market.
