When you hear the word biosimilar, you might think it’s just another generic drug. But it’s not. Biologics aren’t made in a lab with chemicals-they’re grown in living cells, like yeast or bacteria. That makes them incredibly complex. And because of that complexity, the rules for when a copy can enter the market are nothing like the ones for your everyday pills. In the U.S., a biosimilar can’t just wait for a patent to expire. It has to wait for a whole other system to run its course-one designed to protect drugmakers for over a decade.
The 12-Year Lockout
The U.S. doesn’t let biosimilars in until 12 years after the original biologic gets FDA approval. That’s not a patent expiration date. That’s a government-mandated market lockout. Even if the original patent on a drug like Humira expires in 2016, the FDA still can’t approve a copy until 2023. That’s because of the Biologics Price Competition and Innovation Act (BPCIA) from 2009. This law created a two-part clock: a 4-year data exclusivity period, then an 8-year period where biosimilars can be submitted for review but not approved. The 12-year mark is the hard stop.This system was meant to balance innovation and competition. Drug companies argue they need that long to recoup the $100 million to $250 million it costs to develop a biosimilar. But patients and insurers pay the price. Between 2012 and 2022, the list price of Humira in the U.S. jumped 470%. Meanwhile, in Europe, where exclusivity lasts only 10 years, prices dropped sharply after biosimilars arrived. Americans paid hundreds of billions more than they needed to.
The Patent Dance That Delays
Even after the 4-year mark, when biosimilar makers can finally file their application, they’re not done. There’s a legal ritual called the “patent dance.” It starts when the biosimilar company sends its application details to the original drugmaker. That company then picks which patents they think are being violated. The biosimilar maker responds, explaining why they don’t infringe. Then both sides negotiate-which often leads to lawsuits.AbbVie, the maker of Humira, filed over 160 patents on the drug, even after its core patent expired. These weren’t all about the medicine itself. Some covered delivery devices, packaging, or dosing schedules. Each one added another layer of legal delay. In one case, the Supreme Court had to step in just to clarify whether the patent dance was even mandatory. It wasn’t. But companies still use it to drag things out. Some lawsuits stretch for years. And while courts sort it out, patients keep paying full price.
Why It’s Harder Than Generics
A generic version of a pill like Lipitor is made of simple chemicals. You can copy it exactly. A biosimilar? It’s made in a living system. Even tiny changes in how it’s grown can affect how it works. That’s why the FDA requires biosimilar makers to prove “no clinically meaningful differences” in safety, purity, or potency. That means extensive lab tests, animal studies, and sometimes even new clinical trials. It’s not just copying. It’s reverse-engineering a living thing.That’s why a generic pill might cost $1 million to develop. A biosimilar? Often over $100 million. And for the most complex ones-like antibody-drug conjugates or cell therapies-it can hit $250 million. That’s why so few companies are willing to try. Only 12 out of 118 biologics set to lose protection between 2025 and 2034 even have biosimilars in development. The rest? They’re sitting there, waiting. And patients are still paying top dollar.
The Biosimilar Void
There’s a growing crisis called the “biosimilar void.” It’s when a biologic’s patent is about to expire, but no one’s making a copy. Why? Three big reasons: cost, complexity, and orphan drugs.Orphan drugs treat rare diseases. They’re expensive to begin with, and the patient pool is small. Biosimilar makers don’t see enough profit to justify the $200 million investment. Eighty-eight percent of expiring biologics with orphan status have no biosimilar in the pipeline. That means patients with rare conditions-like certain autoimmune disorders or cancers-will keep paying $10,000 a month for drugs that could cost a fraction elsewhere.
And then there’s the complexity. Newer biologics aren’t just antibodies. They’re engineered to target multiple pathways at once. Some are fused with toxins to kill cancer cells. Others are live cells injected into the body. These aren’t just hard to make-they’re hard to copy. And the FDA hasn’t yet created clear rules for how to approve copies of these next-gen drugs. So even when patents expire, biosimilars can’t follow.
What’s Happening Elsewhere
The U.S. isn’t the only country with this problem. But it’s the only one with a 12-year lockout. Europe gives 10 years of data exclusivity, then 1 more year of market exclusivity-11 total. Japan and South Korea have similar but shorter windows. And in those places, biosimilars are already mainstream. In Europe, they make up 72% of the market for biologics with copies available. Prices dropped by 50% to 80% within two years.In the U.S., only 38 biosimilars have been approved since 2015. In Europe, it’s 88. The gap isn’t just about regulation. It’s about culture. European doctors and pharmacists trust biosimilars. U.S. providers? Many still don’t. A 2022 survey found 63% of pharmacists had patients who quit their biologic because they couldn’t afford it. And 78% believed the current system delays access unnecessarily.
Who’s Winning and Who’s Losing
The big winners? The original drugmakers. They’ve used the system to extend monopolies far beyond what anyone intended. The losers? Patients, especially those with chronic conditions like rheumatoid arthritis, Crohn’s disease, or cancer. For many, biologics are life-saving. But if they cost $20,000 a year and insurance won’t cover the biosimilar, they’re out of luck.Pharmacies and insurers are stuck in the middle. They want cheaper drugs. But they’re often locked into contracts with the big makers. And even when a biosimilar is approved, it doesn’t automatically replace the original. Doctors have to switch. Patients have to agree. Many don’t. They’re afraid of change. That fear is exploited by marketing campaigns that paint biosimilars as “less safe.” The FDA says they’re not. But the messaging sticks.
What’s Next?
The FDA has tried to fix this. Their 2022 Biosimilars Action Plan promised to improve communication, speed up approvals, and support competition. But progress has been slow. Legislation to streamline the process stalled in Congress. Meanwhile, 16 next-generation biologics-things like gene therapies and bispecific antibodies-are set to lose patent protection between 2025 and 2034. And right now? None have biosimilars in development.The Congressional Budget Office estimates that if we fix the system, biosimilars could save the U.S. healthcare system $158 billion over the next decade. But if we keep things the way they are? Only $71 billion. That’s $87 billion in missed savings. That’s not just money. That’s access. That’s treatment. That’s lives.
There’s no magic fix. But the path forward is clear: shorten the exclusivity window, crack down on patent thickets, fund development for orphan drugs, and educate providers and patients. Until then, the clock keeps ticking-and patients keep paying.
Can a biosimilar be approved before the 12-year exclusivity period ends?
No. Under U.S. law, the FDA cannot approve a biosimilar until 12 years after the reference biologic’s first approval date. This is a hard statutory deadline under the BPCIA, regardless of whether patents have expired or litigation has been resolved. Even if a biosimilar is ready and passes all tests, it must wait for the full 12 years to pass.
Why don’t biosimilars cost much less than the original biologic?
While biosimilars are cheaper than the original, they don’t drop to the same low prices as small-molecule generics because they’re far more complex and expensive to produce. Developing a biosimilar can cost over $100 million, compared to $1-2 million for a generic pill. Plus, patent litigation, lack of provider confidence, and payer contracts often prevent deep price discounts. Even after approval, manufacturers may keep prices high to avoid price wars.
How long does it take to develop a biosimilar?
It typically takes 5 to 9 years to develop a biosimilar, not including the time spent waiting for the 4-year data exclusivity period to end. For complex biologics like antibody-drug conjugates or cell therapies, development can take 7 to 10 years and cost over $250 million. This is far longer than the 2-3 years it takes to make a generic small-molecule drug.
Why are there so few biosimilars for orphan drugs?
Orphan drugs treat rare diseases with small patient populations. The high cost of biosimilar development-often $200 million or more-doesn’t make financial sense when the potential market is tiny. As a result, 88% of expiring biologics with orphan status have no biosimilar in development, even though many patients need affordable options. This creates a major access gap for people with rare conditions.
Is the U.S. the only country with a 12-year exclusivity period?
No. The U.S. has the longest exclusivity period for biologics. The European Union offers 10 years of data exclusivity plus 1 year of market exclusivity (11 total). Japan provides 8 years of data exclusivity and 4 years of market exclusivity (12 total), but only for certain drugs. South Korea offers 10 years of data exclusivity with no additional market exclusivity. The U.S. is unique in combining a strict 12-year clock with aggressive patent strategies that delay competition even further.
