Biosimilars are poised to save patients who depend on expensive biologic drugs thousands of dollars a year, and in some cases, they already are. A biosimilar is a biologic medication that is highly similar to an already-approved reference product, with no clinically meaningful differences in safety or effectiveness. For patients managing conditions like rheumatoid arthritis, multiple sclerosis, cancer, or Crohn’s disease, where brand-name biologics can run anywhere from $22,000 to over $80,000 per year, the arrival of lower-cost biosimilar alternatives represents a genuine financial lifeline. In the first half of 2025, the average 30-day cost for a brand biologic was $2,104, compared to just $919 for a biosimilar — a roughly 56 percent reduction.
For those of us who write about brain health and dementia care, this matters directly. Many neurological conditions, including relapsing multiple sclerosis, are treated with biologic drugs that carry staggering price tags. The November 2025 launch of Tyruko, the first biosimilar for Tysabri (natalizumab), opened a new chapter for MS patients who previously had no lower-cost alternative for that particular therapy. This article will walk through what biosimilars actually are, how much money they can save, which new options have hit the market, what the safety evidence says about switching, and what barriers still stand in the way of broader adoption.
Table of Contents
- How Much Can Biosimilars Save Patients Who Take Expensive Biologics?
- Which New Biosimilars Have Launched and What Do They Treat?
- Is It Safe to Switch from a Brand Biologic to a Biosimilar?
- How to Talk to Your Doctor and Insurance Company About Biosimilars
- What Barriers Still Prevent Wider Biosimilar Adoption?
- How Regulatory Changes Are Accelerating Biosimilar Development
- What Biosimilars Could Mean for Neurological and Dementia-Related Care
- Conclusion
- Frequently Asked Questions
How Much Can Biosimilars Save Patients Who Take Expensive Biologics?
The savings are not theoretical. The RAND Corporation projected $38.4 billion in U.S. savings from biosimilars between 2021 and 2025, while IQVIA estimated that globally, biosimilars would generate $215 billion in savings through 2026. At the individual level, biosimilar prices are on average 50 percent less than the reference biologic at the time of launch. Some of the most dramatic discounts have come from the wave of Stelara biosimilars, which launched at prices up to 85 to 90 percent below the original drug’s cost.
Medicare patients, who often bear a significant share of specialty drug costs, have seen roughly 23 percent lower out-of-pocket expenses when using biosimilars, though the actual savings range from 12 to 45 percent depending on the specific plan and pharmacy. That spread is worth noting — not every patient will see the same reduction, and the details of your insurance formulary matter enormously. A patient on a Medicare Advantage plan with generous specialty tier coverage may save less in percentage terms than someone on a plan with high coinsurance. To put a real number on it: Humira, one of the world’s best-selling drugs, cost roughly $80,000 per year before biosimilar competition arrived. Humira biosimilars captured 14.1 percent of the market in 2024, with prices up to 85 percent less than the original list price. For a patient paying 20 percent coinsurance on a biologic that costs $80,000, that is the difference between $16,000 a year out of pocket and potentially $2,400 or less.
Which New Biosimilars Have Launched and What Do They Treat?
The year 2025 was a landmark for biosimilar approvals, with 16 new biosimilars approved by the FDA in that single year. Among the most significant: six Stelara (ustekinumab) biosimilars launched in the U.S. since February 2025 — Wezlana, Selarsdi, Pyzchiva, Otulfi, Yesintek, and Steqeyma — delivering an estimated 85 percent net savings per claim. Stelara is used to treat psoriasis, psoriatic arthritis, and Crohn’s disease, so these biosimilars affect a large patient population. For neurological conditions specifically, the launch of Tyruko in November 2025 was a milestone.
Tyruko is the first biosimilar of Tysabri (natalizumab), which is prescribed for relapsing forms of multiple sclerosis and Crohn’s disease. Patients who have been stable on Tysabri now have a lower-cost option, though availability and insurance coverage may vary by plan. Other notable 2025 launches include Merilog, the first FDA-approved rapid-acting insulin biosimilar referencing Novolog, and Poherdy, a biosimilar for pertuzumab used in HER2-positive breast cancer. However, if your biologic does not yet have a biosimilar competitor, these savings remain out of reach. High-cost oncology biologics like pembrolizumab (Keytruda) and nivolumab (Opdivo) do not yet have approved biosimilars on the market, though roughly 25 approvals are pending in the pipeline. For patients on those therapies, the wait continues, and it could be several more years before competition drives prices down.
Is It Safe to Switch from a Brand Biologic to a Biosimilar?
This is the question that causes the most anxiety among patients, and the evidence is reassuring. An FDA meta-analysis and over a decade of real-world data show no increased risk when patients switch from a reference biologic to a biosimilar. Adverse event rates did not differ significantly between groups in studies spanning rheumatology, oncology, gastroenterology, and other specialties. The biological mechanism is straightforward: biosimilars are manufactured to be highly similar to the reference product, and while minor differences in inactive ingredients or manufacturing processes exist, they do not produce clinically meaningful differences in how the drug works in your body. The American College of Rheumatology supports the use of biosimilars for increasing access to treatment. That said, the ACR also opposes insurer-mandated non-medical switching without physician input.
The distinction matters. A conversation between you and your doctor about whether a biosimilar is appropriate for your situation is very different from your insurance company forcing a switch purely for cost reasons, without your physician’s agreement. If your insurer notifies you of a formulary change that would move you to a biosimilar, you have the right to ask your doctor whether they support the switch and, if not, to request an exception or appeal. One practical caution: while the clinical data on switching is strong, some patients report subjective differences when changing from one biologic formulation to another. These may relate to injection device design, injection site reactions, or the psychological weight of changing a medication that has been working. None of these are reasons to avoid a biosimilar, but they are worth discussing with your care team so you know what to expect.
How to Talk to Your Doctor and Insurance Company About Biosimilars
If you are currently taking an expensive biologic and a biosimilar alternative exists, the first step is a direct conversation with your prescribing physician. Ask whether a biosimilar is available for your specific medication, whether they have experience prescribing it, and whether they believe it is clinically appropriate for you. Not every biologic has a biosimilar yet, and not every biosimilar is on every insurance formulary. The tradeoff patients often face is between staying on a familiar medication and accepting a new one that costs significantly less. For many, the math is compelling.
Under the Inflation Reduction Act, starting in 2026, Medicare members can get a 30-day supply of Stelara for 66 percent off the list price, bringing it down to around $4,695. But for patients who have been stable on a brand biologic for years, the idea of switching can feel risky even when the data says otherwise. This is where shared decision-making with your doctor is essential — not a unilateral decision by your insurer. If your insurance company is pushing you toward a biosimilar you are uncomfortable with, or if your doctor believes the brand product is more appropriate for your situation, most plans have an appeals or exceptions process. Document the medical rationale, get your physician’s support in writing, and file the appeal. The system is not always easy to navigate, but the option exists.
What Barriers Still Prevent Wider Biosimilar Adoption?
Despite more than 76 biosimilar approvals since 2015, U.S. market penetration remains under 20 percent overall, capturing roughly 23 percent of the biologics market. That is a strikingly low figure given the potential savings involved, and several forces explain it. Pharmaceutical manufacturers of brand biologics have used patent thickets, rebate structures, and legal challenges to delay or discourage biosimilar competition. Pharmacy benefit managers sometimes favor brand drugs because of higher rebates, even when a biosimilar would cost the patient less. Physician and patient awareness also lags.
Many patients have never heard the term “biosimilar,” and some physicians remain cautious about prescribing them, either from unfamiliarity or from concern about triggering insurance complications. High-priced oncology biologics now make up 50 to 60 percent of a cancer patient’s total treatment costs, yet the oncology biosimilar market is still in its infancy compared to rheumatology or gastroenterology. There is also a geographic limitation. Biosimilar availability can vary by pharmacy, and specialty pharmacies may not stock all options. Patients in rural areas or those relying on specific infusion centers may have fewer choices. If your local infusion center only carries the brand product, the biosimilar savings become academic unless you can access a different provider.
How Regulatory Changes Are Accelerating Biosimilar Development
The FDA has been actively working to lower the barriers for biosimilar developers. In November 2025, the agency announced it would eliminate routine switching and comparative efficacy studies for biosimilar approval, relying instead on advanced analytical methods. This change is expected to reduce development costs by up to $100 million per drug, which should encourage more manufacturers to enter the market.
Then in March 2026, the FDA issued new draft guidance to streamline pharmacokinetic testing, potentially saving developers up to 50 percent of PK study costs — roughly $20 million per program. These regulatory shifts matter for patients because every dollar saved in development is a dollar that does not need to be recouped through drug pricing. Faster, cheaper biosimilar development means more competition, more options, and ultimately lower prices at the pharmacy counter. The pipeline of approximately 25 pending biosimilar approvals, including competitors for blockbuster oncology drugs like Keytruda and Opdivo, suggests that the next few years will bring even more choices for patients on expensive biologics.
What Biosimilars Could Mean for Neurological and Dementia-Related Care
The intersection of biosimilars and brain health is still narrow, but it is growing. Tyruko’s launch as the first Tysabri biosimilar directly affects MS patients, many of whom are managed by the same neurologists who treat dementia and other neurodegenerative conditions.
As the biologic pipeline expands into neurological indications — and as more conditions are treated with targeted biologic therapies — the availability of affordable biosimilars will matter increasingly for patients with brain-related diseases. Looking ahead, the combination of regulatory streamlining, growing physician comfort, and mounting financial pressure on the healthcare system all point toward broader biosimilar adoption. For patients and caregivers already navigating the costs of long-term neurological care, keeping an eye on biosimilar options is a practical step that could meaningfully reduce the financial burden of treatment.
Conclusion
Biosimilars represent one of the most concrete opportunities for patients on expensive biologics to reduce their treatment costs without sacrificing safety or effectiveness. The evidence from more than a decade of use, backed by FDA analysis and real-world studies, shows that switching from a brand biologic to a biosimilar carries no increased risk of adverse events. With average savings of 50 percent at launch and some biosimilars priced 85 to 90 percent below the original, the financial impact can be substantial for patients paying thousands out of pocket each year.
The path forward requires patients to be informed advocates for themselves. Ask your doctor whether a biosimilar exists for your medication, check whether it is covered on your insurance formulary, and understand your rights if your insurer mandates a switch you are not comfortable with. The biosimilar market is still maturing — penetration remains under 20 percent despite dozens of approvals — but the trend is clear, and the next few years should bring even more options, including for high-cost oncology and neurological therapies.
Frequently Asked Questions
What is the difference between a biosimilar and a generic drug?
A generic drug is a chemical copy of a small-molecule medication, identical in structure. A biosimilar is a biologic product that is highly similar to a reference biologic but not an exact copy, because biologics are made from living cells and are far more complex than chemical drugs. The FDA requires biosimilars to demonstrate no clinically meaningful differences in safety, purity, or potency compared to the reference product.
Will my insurance cover a biosimilar?
Coverage varies by plan and formulary. Many insurers are adding biosimilars to their formularies because of the lower cost, and some are actively encouraging or requiring switches. Check with your plan directly, and ask your doctor whether the specific biosimilar is covered under your prescription benefits.
Can my doctor refuse to switch me to a biosimilar?
Yes. The American College of Rheumatology and other medical organizations support physician-led decision-making regarding biosimilar switching. If your doctor believes the brand product is more appropriate for you, they can advocate on your behalf through your insurer’s exceptions or appeals process.
Are biosimilars available for MS treatments?
As of late 2025, Tyruko became the first biosimilar for Tysabri (natalizumab), used in relapsing MS. Other MS biologics do not yet have biosimilar competitors, but the pipeline is expanding as patents expire and regulatory barriers decrease.
How much can I realistically save by switching to a biosimilar?
Medicare patients have seen an average of 23 percent lower out-of-pocket costs, though the range is 12 to 45 percent depending on the plan. At launch, biosimilars are typically priced about 50 percent below the reference biologic, with some newer entries like Stelara biosimilars launching at 85 to 90 percent below original prices.
Will biosimilar prices keep dropping?
Competition tends to drive prices down over time. As more biosimilars enter the market for the same reference product, pricing pressure increases. Regulatory changes in 2025 and 2026 that reduce development costs by up to $100 million per drug should also encourage more manufacturers to compete, which historically leads to further price reductions.
