Quick Answer: As of 2026, the FDA has approved 84 biosimilars as alternatives to expensive brand-name biologics. These drugs treat conditions like rheumatoid arthritis, Crohn's disease, cancer, and diabetes, and their list prices typically run 15 to 85 percent below the reference biologic. Medicare Part D plans are increasingly covering biosimilars over brand-name products.
If you take a biologic drug for rheumatoid arthritis, Crohn's disease, psoriasis, or cancer, your annual drug costs can easily exceed $50,000. Biologics make up only 5% of U.S. prescriptions but account for 51% of total drug spending as of 2024. Biosimilars exist precisely to lower that burden, and in 2026 the landscape for patients is meaningfully better than it was even two years ago.
This guide explains what biosimilars are, which brand-name biologics now have approved alternatives, what they cost, how Medicare and Medicaid cover them, and the steps to ask your doctor about switching.
What Is a Biosimilar?
A biosimilar is a biological medicine that the FDA has determined to be highly similar to an already-approved reference biologic, with no clinically meaningful differences in safety, purity, or potency. The word "biosimilar" is not just marketing language. It is a regulatory classification that requires manufacturers to submit clinical data demonstrating that their product works the same way as the original.
Biosimilars are not generic drugs in the traditional sense. Because biologics are made from living cells rather than chemical synthesis, exact duplication is not possible. The FDA's approval standard is instead "highly similar" plus "no clinically meaningful differences" in the way the drug behaves in patients.
An interchangeable biosimilar is a higher standard still. An interchangeable product can be substituted at the pharmacy counter without the prescribing physician having to write a new prescription, the same way a pharmacist can substitute a generic for a small-molecule drug. In 2026, several biosimilars have earned interchangeable designation, which simplifies the switching process for patients.
FDA-Approved Biosimilars in 2026: The Full Picture
As of May 2026, the FDA has approved 84 biosimilars, up from 40 just four years ago. The FDA's Purple Book database maintains the current list. The most recent 2026 approval was Langlara (insulin glargine-aldy), approved on April 29, 2026.
Key therapeutic categories with available biosimilars in 2026:
| Condition | Reference Biologic | Biosimilar Alternatives Available (2026) |
|---|
| Rheumatoid arthritis, psoriasis | Humira (adalimumab) | 10 biosimilars including Hadlima, Hyrimoz, Cyltezo, Yusimry |
| Crohn's disease, ulcerative colitis | Stelara (ustekinumab) | 6 biosimilars including Wezlana, Selarsdi, Pyzchiva, Steqeyma |
| Rheumatoid arthritis, Crohn's | Remicade (infliximab) | Multiple including Inflectra, Renflexis, Avsola |
| Cancer (neutropenia support) | Neupogen (filgrastim) | Zarxio, Nivestym, Releuko, Filkri |
| Osteoporosis | Prolia (denosumab) | Ponlimsi (Teva, FDA-approved 2026) |
| Ophthalmologic conditions | Eylea (aflibercept) | Yesafili, Opuviz |
| Diabetes | Lantus (insulin glargine) | Multiple including Basaglar, Semglee, Langlara |
| Breast cancer, gastric cancer | Herceptin (trastuzumab) | Multiple including Herzuma, Kanjinti, Ogivri |
The 2026 additions in cancer care and osteoporosis are particularly significant. Denosumab (Prolia) costs $2,000 to $3,500 per injection at brand-name prices. A biosimilar alternative at even a 30% discount saves patients hundreds of dollars per dose.
What Biosimilars Actually Cost vs. Brand Biologics
Biosimilars launched in the U.S. market enter at prices typically 15 to 35 percent below the reference biologic's list price. Over time, as more biosimilars compete for the same reference product, discounts deepen. Products with 5 or more competitors often see prices 60 to 85 percent below the original brand's price at the time of first biosimilar launch.
The aggregate numbers show the scale of the opportunity: biosimilars have generated $56 billion in healthcare savings since 2015, with $20 billion saved in 2024 alone, according to HHS data.
For Humira specifically, brand-name adalimumab cost roughly $8,500 to $9,200 per claim in 2023. With 10 biosimilar competitors now on the market, net prices have dropped substantially. The 2026 Medicare Part D out-of-pocket maximum is $2,100, which means no Medicare Part D beneficiary should pay more than that for any drug in a calendar year.
Practical out-of-pocket comparison for a Medicare beneficiary:
- Brand Humira (adalimumab): Often placed on specialty tier with 25-33% coinsurance before the 2026 out-of-pocket cap
- Humira biosimilar: Increasingly placed on preferred specialty tier by major Part D plans, potentially lower coinsurance
- Once you hit the 2026 Part D cap of $2,100, all further drug costs are $0 for the rest of the year
How Medicare Covers Biosimilars in 2026
Medicare covers biosimilars through two pathways depending on how the drug is administered.
Medicare Part B covers biologics administered in a clinical setting, like infusions for Crohn's disease or cancer. For Part B drugs, Medicare reimburses at average sales price plus a percentage add-on. To encourage biosimilar use, the Inflation Reduction Act temporarily increased the add-on for qualifying biosimilars to 8% (versus 6% for the reference biologic), a policy designed to make biosimilars more financially attractive to the providers administering them.
Medicare Part D covers self-administered biologics, including the adalimumab autoinjectors most rheumatoid arthritis patients use at home. Coverage of biosimilars in Part D has accelerated sharply. The HHS Office of Inspector General found that most Medicare Part D plans included Humira biosimilars on their 2025 formularies. By 2026, major pharmacy benefit managers including CVS Caremark, Optum Rx, and Express Scripts have moved to exclude brand-name Humira and Stelara in favor of biosimilars on their formularies.
One complexity: formulary placement affects what tier a drug lands on, and tier placement determines patient cost-sharing. Ask your pharmacist or plan representative which tier your biosimilar is on and compare it to the brand-name product before assuming the biosimilar is cheaper on your specific plan.
Medicare Savings Programs can further reduce your drug costs if you have limited income. These programs help pay Medicare Part B premiums, deductibles, and copayments. Check your eligibility at coveredusa.org/screener.
How Medicaid Covers Biosimilars
Medicaid covers FDA-approved biosimilars in all states. Under federal Medicaid law, states must cover all FDA-approved drugs unless they have an approved exclusion. Because biosimilars are approved products, Medicaid plans are required to provide access.
In practice, many state Medicaid programs prefer biosimilars over brand-name biologics because biosimilars cost less and the savings flow back to state budgets. If you are on Medicaid and your doctor writes a prescription for a brand-name biologic, your pharmacy may automatically substitute an interchangeable biosimilar without a new prescription.
If you are not sure whether you qualify for Medicaid, your income, household size, and state determine eligibility. You can check your eligibility at CoveredUSA in about 2 minutes.
How to Switch from a Brand Biologic to a Biosimilar
Switching requires a conversation with your prescribing physician. Do not attempt to switch on your own by requesting substitutions without medical guidance, especially for conditions like Crohn's disease or cancer where treatment stability matters.
Here is a practical step-by-step approach for 2026:
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Check if a biosimilar exists for your drug. Search the FDA Purple Book by your drug's reference product name. Look for products with "interchangeable" status if you want the simplest pharmacy substitution.
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Ask your doctor at your next appointment. Say: "I see there are biosimilar alternatives to [drug name]. Is switching appropriate for my condition given where I am in treatment?" New patients starting a biologic are generally the easiest candidates for biosimilar use. Patients who have been stable on a brand biologic for years face a different clinical conversation.
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Call your insurance plan or pharmacy benefit manager. Ask: "Is [biosimilar name] on my formulary, and what tier is it on compared to [brand-name biologic]?" The tier determines your out-of-pocket cost.
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Check the manufacturer's patient assistance program. Some brand-name biologic manufacturers offer copay cards that can make the brand drug cheaper than the biosimilar after applying discounts. Calculate both options before deciding.
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Ask about interchangeability. If the biosimilar you want has FDA interchangeable designation, your pharmacist can substitute it directly. If not, your doctor needs to write a new prescription for the specific biosimilar product.
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Documents you may need for a formulary exception: A letter of medical necessity from your doctor, documentation of prior treatment with the reference biologic, and any relevant lab results or clinical history.
Common reasons a switch request may be denied:
- The biosimilar is not on your plan's formulary
- Your doctor documented that you require the specific reference product for medical reasons
- The plan requires prior authorization for biosimilar products (less common, but it happens)
- You are mid-treatment in a clinical trial that specifies the reference biologic
The 2026 FDA Push to Accelerate Biosimilar Access
In early 2026, the FDA announced steps to streamline biosimilar development, including reducing unnecessary clinical pharmacokinetic testing requirements. The FDA estimates this change alone could save biosimilar developers up to $20 million per product and cut testing costs by 50%. Analysts expect annual biosimilar approvals to jump from 8 to 10 per year to 15 to 20, which means more competition and lower prices for conditions where biologics are currently the only option.
The HHS fact sheet on biosimilars notes that biologics account for 51% of total drug spending despite representing only 5% of prescriptions. Expanding biosimilar competition is one of the few policy tools that can structurally reduce that imbalance without rationing access to treatment.
Does Your Insurance Cover Your Biologic or Biosimilar?
Coverage for biologics and biosimilars varies significantly by plan type, state, and specific drug. Here is a summary of what to expect across the main coverage types:
| Coverage Type | Biosimilar Access | Notes |
|---|
| Medicare Part B | Generally covered | 8% add-on incentive for biosimilars; ask your infusion center |
| Medicare Part D | Increasingly preferred over brand | Check your plan's formulary; out-of-pocket cap is $2,100 in 2026 |
| Medicaid | Required to cover all FDA-approved biosimilars | State programs may prefer biosimilars to control costs |
| ACA marketplace plans | Varies by plan and formulary | Silver and higher plans typically cover specialty drugs |
| Employer insurance | Varies widely | PBMs increasingly shifting to biosimilar-preferred formularies |
If you are uninsured or underinsured, access to biologics and biosimilars is extremely difficult without assistance programs. Your best starting point is finding out if you qualify for Medicaid, Medicare, or ACA marketplace coverage. Use the free screener at coveredusa.org/screener to find out in 2 minutes.
Frequently Asked Questions
Are biosimilars as safe and effective as brand-name biologics?
Yes. The FDA requires biosimilars to demonstrate no clinically meaningful differences in safety, purity, or potency compared to the reference biologic. The FDA's approval standard includes comprehensive data on how the drug works in the body, not just structural similarity. The clinical evidence supporting biosimilar safety and effectiveness is extensive, and both the FDA and CMS have confidence in approved products.
What is the difference between a biosimilar and an interchangeable biosimilar?
An interchangeable biosimilar has met an additional FDA standard allowing pharmacists to substitute it for the reference biologic without a new prescription from the doctor, the same way generics work. A non-interchangeable biosimilar still requires a doctor's prescription specifying that product. In 2026, several adalimumab and insulin biosimilars carry interchangeable status, making them the simplest to access.
Will I notice a difference if I switch from Humira to a Humira biosimilar?
Clinical studies used to support biosimilar approval include data on patients who switch from the reference biologic. Regulatory approvals would not have occurred if switching caused meaningful clinical differences. That said, individual patient responses vary, and your doctor should monitor you after any medication change. Most patients who switch report no perceptible difference.
Does Medicare pay less for biosimilars than for brand biologics?
For Part B drugs, Medicare pays the biosimilar manufacturer at the biosimilar's average sales price plus 8%, versus 6% add-on for the brand biologic. This slightly higher add-on is designed to encourage providers to use biosimilars. For Part D, what you pay depends on which tier your plan places the drug on. Check your plan's drug formulary directly at medicare.gov or call 1-800-MEDICARE.
My doctor says I should stay on the brand-name biologic. Can I push back?
You can ask your doctor to explain the clinical reasoning. For patients who are newly starting a biologic, there is rarely a clinical reason to start on the brand rather than the biosimilar. For patients who have been stable on a brand biologic, some doctors prefer not to change a stable treatment. The FDA and major rheumatology and gastroenterology societies generally support biosimilar use, including switching, when done under physician supervision.
Can I get help paying for a biologic or biosimilar if I have no insurance?
Most major biologic manufacturers offer patient assistance programs for uninsured patients. Some biosimilar manufacturers do as well. These programs can provide the drug free or at very low cost based on income. You should also check whether you qualify for Medicaid, which would cover your drug with minimal or no out-of-pocket cost. Check your eligibility at CoveredUSA to find out whether you qualify for Medicaid, Medicare, or ACA marketplace coverage.
How do I know which biosimilars are approved for my condition?
The FDA's Purple Book database is the authoritative source. Search by the reference biologic name to see all approved biosimilars for that product, along with their interchangeable status and approved indications. The Center for Biosimilars also tracks recent approvals and market launches.
What happens if my pharmacy cannot fill a biosimilar?
If your plan formulary lists a biosimilar but your local pharmacy does not stock it, ask the pharmacy to order it or use your plan's mail-order pharmacy option. Specialty pharmacies, which handle high-cost drugs like biologics, typically carry all formulary-listed biosimilars. Your insurance plan can provide a directory of in-network specialty pharmacies.
Check your eligibility now at CoveredUSA. It takes 2 minutes. If your biologic costs are creating a financial burden, qualifying for Medicaid, Medicare Savings Programs, or ACA marketplace coverage could dramatically reduce what you pay. Use the free screener at coveredusa.org/screener to see every program you may qualify for based on your income, age, and household size.
