Biologic Patent Protection: When Biosimilars Can Enter the U.S. Market

When you hear the word biosimilar, you might think it’s just like a generic drug. But it’s not. Biologics aren’t made in a lab with chemicals-they’re grown in living cells. Think insulin, cancer drugs like Humira, or treatments for rheumatoid arthritis. These aren’t simple molecules. They’re complex, living products. And because of that, copying them isn’t like copying aspirin. That’s why the rules around when biosimilars can enter the market are so strict, so long, and so full of legal traps.

How Long Do Biologics Get Protected?

In the U.S., the clock starts ticking the day the FDA approves a new biologic drug. From that moment, the manufacturer gets 12 years of market exclusivity. That means no biosimilar can be approved during that time. But here’s the catch: even before those 12 years are up, biosimilar makers can’t even submit their application until 4 years after the original drug’s approval. So for the first four years, no one can apply. For the next eight, they can apply-but the FDA can’t approve anything. That’s not just protection. It’s a full 12-year monopoly.

This system was created by the Biologics Price Competition and Innovation Act (BPCIA) in 2010. The idea was to reward innovation while eventually letting cheaper versions in. But in practice, it’s meant that drugs like Humira stayed the only option in the U.S. for over a decade, even after biosimilars were already available in Europe and Canada. By the time Humira’s first U.S. biosimilar arrived in 2023, it had been on the market for seven years in Europe. American patients paid hundreds of millions more because of that delay.

The Patent Dance: A Legal Maze

Even after the 4-year mark, biosimilar companies don’t just file paperwork and wait. They’re forced into something called the “patent dance.” It sounds polite. It’s anything but.

Within 20 days of submitting their application, the biosimilar maker must hand over their entire manufacturing plan and clinical data to the original drug company. The original company then has 60 days to list every patent they think might be violated-even patents that have nothing to do with the drug’s active ingredient. Then the biosimilar maker gets another 60 days to respond, explaining why each patent doesn’t apply. After that, both sides enter a 15-day negotiation to pick which patents will go to court.

Most of the time, they don’t agree. That’s when the lawsuits start. And they don’t end quickly. AbbVie, the maker of Humira, filed over 160 patents on the drug-even though the core patent expired in 2016. They didn’t need to win them all. They just needed to drag out the process. By the time the first biosimilar was approved in 2023, AbbVie had spent years in court, delaying competition and keeping prices high.

It’s not just about patents. It’s about timing. Companies use the patent dance to stretch out exclusivity beyond the 12-year mark. Some have managed to delay biosimilars for 15 years or more. That’s not innovation. That’s legal gaming.

Why Are Biosimilars So Expensive to Make?

It’s not just the law that slows down biosimilars. It’s the science.

A generic pill? You can make it in two years for about $1 million. A biosimilar? It takes five to nine years. And it costs more than $100 million. For complex biologics like antibody-drug conjugates or cell therapies, the price jumps to $250 million. Why? Because these drugs are made from living cells. Every batch is slightly different. Every step-cell culture, purification, storage-has to be perfectly controlled. Even tiny changes can affect safety.

That’s why the FDA requires more than just lab tests. Biosimilar makers have to prove their product is “highly similar” to the original-with no clinically meaningful differences in safety, purity, or effectiveness. That often means running new clinical trials. It’s not enough to say “it’s the same.” You have to prove it, over and over, with real patients.

That’s why so few companies try. Pfizer, Amgen, and Sandoz are the big players. Smaller firms don’t have the cash. And when the original drug is for a rare disease, the market is too small to justify the cost. That’s why, out of 118 biologics set to lose patent protection between 2025 and 2034, only 12 have biosimilars in development. For orphan drugs-treatments for rare diseases-88% have no biosimilar in the pipeline at all.

The Global Picture: Why the U.S. Is Behind

Compare the U.S. to Europe. In the EU, biologics get 10 years of data exclusivity, plus one year of market exclusivity. That’s 11 years total-less than the U.S. And they don’t have a patent dance. Once the exclusivity period ends, biosimilars can enter quickly. By 2023, biosimilars made up 72% of the market for biologics in Europe. In the U.S.? Less than 10%.

The difference isn’t just rules. It’s culture. European doctors and pharmacists trust biosimilars. In the U.S., many still think they’re “second-rate.” Insurance companies often don’t cover them unless the original drug is too expensive. And patients? They’re afraid to switch. Even if the science says it’s safe, the fear sticks.

That’s why the same drug-say, adalimumab (Humira)-costs 300% more in the U.S. than in Germany or the U.K. Patients in America pay more, not because the drug is better, but because the system blocks competition.

Who’s Winning? Who’s Losing?

The original drug companies win. They get to keep high prices for over a decade. They make billions. AbbVie made over $20 billion a year from Humira alone before biosimilars arrived.

Patients lose. People with autoimmune diseases, cancer, or rare conditions often can’t afford these drugs. One survey found that 63% of pharmacists had patients who stopped taking their biologic because they couldn’t pay. Others switched to cheaper, less effective treatments-or didn’t treat at all.

Healthcare systems lose too. The Congressional Budget Office estimated that if biosimilars could enter faster, the U.S. could save $158 billion over the next decade. Under the current system? Only $71 billion. That’s $87 billion in missed savings. That’s enough to cover insulin for millions of diabetic patients for years.

What’s Changing?

There are signs of movement. The FDA has started pushing to make the approval process faster. They’ve created new guidance to help companies navigate complex biologics. They’re trying to reduce the number of unnecessary clinical trials. But progress is slow.

Legislation like the Biosimilars User Fee Act of 2022 tried to speed things up. It stalled in Congress. Big pharma lobbied hard against it. They don’t want to lose their monopoly.

Some states are trying to step in. California and New York have passed laws requiring pharmacists to substitute biosimilars unless the doctor says no. That’s helping build trust. But it’s not enough.

The real turning point will come when biosimilars start hitting the market for the next wave of expensive biologics-like cancer drugs, gene therapies, and cell treatments. If they’re priced 30-50% lower, doctors will start prescribing them. Patients will switch. And the cycle will begin to change.

What’s Next?

Between 2025 and 2034, 118 biologics will lose patent protection. That’s $234 billion in potential savings. But if nothing changes, only a fraction of those will ever see biosimilars.

The biggest threat isn’t science. It’s the legal system. As long as companies can use patent thickets and endless lawsuits to delay competition, patients will keep paying too much. The solution isn’t to remove patents. It’s to stop letting them be weaponized.

Until then, the U.S. will keep lagging behind the rest of the world. And patients will keep paying the price.