Ninety percent of the biologic medicines facing patent expiration by 2034 have no lower-cost alternative under development, according to a report released Sept. 10 and detailed by The Wall Street Journal. With 118 biologics due to lose protection over the decade, the group behind the analysis puts the potential savings at stake at close to $200 billion.
One disclosure belongs at the top. The estimate comes from the Association for Accessible Medicines, the trade association representing generic and biosimilar manufacturers, and was produced with the IQVIA Institute. Its members are the companies that would build these alternatives and benefit from the policy changes it is urging. That does not make the patent-expiration counts wrong. An earlier IQVIA Institute assessment of the biosimilar void reached the same 90 percent figure and valued the decade of expirations at more than $230 billion in potential market opportunity. Still, the source has a commercial interest in the conclusion.
For households, the stakes are concrete. Biologics include many drugs used for rheumatoid arthritis, Crohn's disease, psoriasis, multiple sclerosis, and several cancers. They generate the coinsurance bills large enough to reshape a family budget, and competition is what has historically brought their prices down.
The Difference Between a Generic and a Biosimilar
A generic is a chemical copy. Manufacturers can reproduce a small-molecule pill exactly, show that it behaves the same way in the body, and launch soon after the primary patent expires. Prices fall quickly.
Biologics are different. They are large, complex proteins grown inside living cells, and no two manufacturing runs are identical. A biosimilar is therefore highly similar rather than identical, needs its own clinical program, and follows a separate regulatory pathway. Development can run into the hundreds of millions of dollars and take years, so companies attempt it only when the expected return justifies the cost.
That economic filter explains the pattern. Development clusters around the highest-selling biologics with near-term expirations, while drugs with smaller markets, later expirations or rare-disease indications attract little interest.
Where the Savings Landed, and Where They Stalled
The same association's annual savings report, also released this month, found that generic and biosimilar medicines saved the United States $496 billion in 2025 and more than $3.6 trillion over the past decade. Together they accounted for 89 percent of prescriptions filled while representing 12 percent of prescription drug spending. About 4 billion generic prescriptions cost $106 billion last year, against 485 million brand-name prescriptions costing $804 billion.
Biosimilars alone have generated $81.6 billion in savings since the first one launched in 2015 and have supported nearly 3.8 billion days of patient therapy, including close to 571 million additional days of treatment the association attributes to biosimilar competition.
"Biosimilars represent one of the most powerful tools we have to expand access," said Alex Keeton, executive director of the Biosimilars Council, the association's biosimilar division. Keeton said the sector still faces barriers involving market access, pricing, pharmacy benefit managers and patent litigation despite recent regulatory progress.
Some of that regulatory movement is independently documented. In October 2025, the Food and Drug Administration proposed dropping comparative efficacy studies as a default requirement, a step that can take one to three years and cost about $24 million. In March, the agency followed with a revision that would reduce certain duplicative clinical studies and let developers use comparator products licensed outside the United States. The FDA estimated the change could cut pharmacokinetic study costs by up to half, or roughly $20 million per program. Both documents remain draft guidance rather than final policy.
The Patients Most Exposed to a Missing Competitor
Not everyone feels a missing biosimilar equally. The sharpest exposure sits with patients on coinsurance rather than flat copays, since a percentage of a high list price scales with the drug's cost. Medicare beneficiaries taking clinician-administered biologics, people with rare diseases and patients in high-deductible plans face the same arithmetic.
Rare-disease patients are structurally disadvantaged. IQVIA found that 75 of the 118 expiring biologics, about 64 percent, carry orphan indications, and that 88 percent of those with at least one orphan indication have no biosimilar in the pipeline. Small patient populations make clinical trials harder to run and development costs harder to recover, so the drugs with the fewest alternatives are often prescribed to patients with the fewest options.
MedicalDaily has previously examined the broader pharmaceutical patent cliff and its implications for global drug pricing.
Steps Patients Can Take While Policy Is Unsettled
A patent expiration by itself changes nothing at the pharmacy counter. Patients on a biologic can ask the prescriber whether an approved biosimilar already exists for their specific product, since several widely used biologics do have one, and ask the plan whether switching would lower out-of-pocket costs. A biosimilar is not automatically cheaper on every formulary.
Nobody should stop or switch a biologic without the prescribing clinician. For people struggling with cost, the practical routes are a formulary exception request, a plan appeal, manufacturer patient-assistance programs and, for Medicare enrollees, the annual out-of-pocket cap on Part D drugs.
The association is using the report to press Congress and regulators on patent thickets, reimbursement rules, pharmacy benefit manager incentives and further streamlining of FDA review. Whether any of that changes a patient's bill depends on decisions not yet made.
Key Questions Answered
What is the finding? A report from the Association for Accessible Medicines says 90 percent of the 118 biologics losing patent protection by 2034 have no biosimilar in development, putting close to $200 billion in projected savings at risk.
Who produced the estimate, and do they have a stake? The trade group for generic and biosimilar manufacturers, working with the IQVIA Institute. Its members would develop and sell the missing alternatives, so the conclusion aligns with their commercial interest.
What is a biosimilar? A highly similar version of a biologic, a complex medicine produced in living cells. Because it cannot be copied exactly, it requires its own clinical testing and a separate FDA pathway.
Does this mean prices will rise? No. It means prices for affected drugs are less likely to fall than they did for earlier biologics that attracted competition. Nothing increases because of this report.
Which patients should pay closest attention? People on coinsurance rather than flat copays, Medicare beneficiaries using clinician-administered biologics, patients with rare diseases, and anyone on a high-deductible plan.
What can a patient do now? Ask the prescriber whether an approved biosimilar exists for their drug, ask the plan whether it costs less, and pursue formulary exceptions, appeals, or assistance programs if cost is a barrier. Do not change a biologic without the prescriber.
