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

Biologic drugs like Humira, Enbrel, and Remicade have changed how we treat autoimmune diseases, cancer, and chronic conditions. But they’re also some of the most expensive medicines on the market. A single dose of Humira can cost over $7,000 in the U.S., while the same drug costs less than $1,000 in Europe. Why? The answer isn’t just about research costs-it’s about biologic patent protection and how the law delays competition.

How Long Do Biologics Get Protected?

In the U.S., the law gives brand-name biologic makers 12 years of market exclusivity after FDA approval. That’s not just a patent-it’s a legal wall. For the first four years, no one can even apply to make a copy. For the next eight years, companies can submit applications, but the FDA can’t approve them. Only after 12 years can a biosimilar legally hit the market.

This isn’t how small-molecule generics work. A generic pill like metformin can be approved in as little as two years after the brand version’s patent expires. But biologics? They’re made from living cells, not chemicals. That makes them harder to copy exactly. So the FDA treats them differently. The 12-year clock starts the day the original drug gets approved-not when the patent is filed. For Humira, that means its 12-year clock started in 2002. But it didn’t face its first U.S. biosimilar until 2023, 21 years later. Why? Because of patent thickets.

The Patent Thicket Problem

Patents aren’t just one document. Companies like AbbVie pile on hundreds. For Humira alone, AbbVie filed over 160 patents covering everything from manufacturing methods to dosing schedules. Even when the core patent expired in 2016, these other patents kept competitors out. That’s called a patent thicket-legal noise designed to delay competition.

There’s also something called the “patent dance.” It’s a complicated, optional negotiation process between the brand drug maker and the biosimilar company. The biosimilar applicant must share its application and manufacturing details. The brand company then picks which patents it wants to sue over. The biosimilar responds. Then they negotiate-which often leads to lawsuits that last years. In one case, Amgen sued Sandoz over Humira biosimilars. The legal battle went all the way to the Supreme Court in 2017. These lawsuits don’t always end in a clear win. But they delay entry. And every delay means higher prices for patients.

Why the U.S. Is Behind Europe and Japan

Europe gives biologics only 10 years of data exclusivity, plus one year of market exclusivity-11 total. Japan gives 8 years of data exclusivity, then 4 more years of market protection. Both still have longer protection than generics, but shorter than the U.S.

Result? Humira got biosimilars in Europe in 2018. In the U.S.? Not until 2023. During those five years, American patients paid an extra $167 billion for biologics that were already cheaper elsewhere. The same pattern happened with Enbrel and other top-selling drugs. Patients in the U.S. are paying 300% more than patients in Europe for the same treatment.

Biosimilars Are Expensive to Make

Making a biosimilar isn’t like copying a pill. You can’t just reverse-engineer it. Biologics are made from living cells-human or animal-which means every batch is slightly different. To prove a biosimilar is safe and effective, companies must run dozens of tests: protein structure analysis, immune response studies, pharmacokinetic trials, and sometimes even full clinical trials.

Pfizer says developing a biosimilar takes 5 to 9 years and costs more than $100 million. For complex drugs like antibody-drug conjugates or gene therapies, costs can hit $250 million. Compare that to a generic pill, which costs $1-2 million and takes two years. 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, Few Competitors

Between 2025 and 2034, 118 biologics will lose their exclusivity. That’s a $234 billion market opportunity. But only 12 of them have biosimilars in development.

Why? Three big reasons:

• Patent timing: If a drug’s patent expires in 2027 but the exclusivity clock ends in 2029, companies wait. Why spend $100 million if you can’t sell until two years later?
• Orphan drugs: 64% of expiring biologics treat rare diseases. Small patient pools mean less profit. Only one orphan drug, eculizumab, has a biosimilar in the pipeline. 88% of orphan biologics have none.
• Complexity: Newer drugs like bispecific antibodies and cell therapies are too complicated for most companies to copy. None have biosimilars in development-even though 16 will lose protection by 2034.

This gap is called the “biosimilar void.” It’s not a glitch-it’s a system failure. Companies aren’t investing because the payoff is too uncertain. And patients are stuck paying high prices for drugs that could be cheaper.

Who’s Winning? Who’s Losing?

The big pharma companies win. They keep prices high and extend monopolies with legal tactics. The FDA wins too-they get to approve more drugs without pressure to speed things up.

Patients lose. So do insurers and employers who pay the bills. A 2022 survey by the National Community Pharmacists Association found that 63% of pharmacists had patients who stopped taking their biologic because they couldn’t afford it. People with rheumatoid arthritis, Crohn’s disease, or psoriasis are skipping doses or going without treatment.

Doctors are frustrated. Dr. Peter Bach from Memorial Sloan Kettering said the U.S. system creates a “perfect storm” for high drug prices. He pointed out that cancer patients in the U.S. pay far more for the same biologics used in Europe.

What’s Being Done?

The FDA released a Biosimilars Action Plan in 2022. It promises better communication, faster reviews, and more support for developers. But so far, little has changed. The Biosimilars User Fee Act of 2022 tried to cut red tape, but it stalled in Congress.

Some states are trying to step in. A few have passed laws allowing pharmacists to substitute biosimilars without a doctor’s permission-similar to how generics work. But federal law still blocks full substitution in many cases.

Meanwhile, the Congressional Budget Office estimates that if we fix the system, biosimilars could save the U.S. $158 billion over the next decade. Under current rules? Only $71 billion.

What Comes Next?

The next wave of expiring biologics includes drugs for rare cancers, multiple sclerosis, and severe asthma. If nothing changes, these will join Humira and Enbrel as expensive drugs with no affordable alternatives.

Real change needs three things:

1. Shorter exclusivity-10 years, not 12.
2. Clearer rules on patent litigation-no more patent thickets.
3. Financial incentives for developers to tackle complex or orphan drugs.

Without these, the U.S. will keep falling behind. Patients will keep paying more. And the promise of biosimilars-cheaper, safer, life-changing medicines-will stay out of reach.