The Arrival of Humira Biosimilars
For nearly two decades, Humira (adalimumab) was the best-selling drug in the world, generating over $200 billion in lifetime revenue for AbbVie. With annual costs exceeding $80,000 per patient at list price, Humira represented both a medical breakthrough for autoimmune diseases and a financial burden for the healthcare system. The launch of Humira biosimilar products in the United States, beginning in January 2023, marked a turning point that promised meaningful cost relief for millions of patients.
As of 2026, multiple Humira biosimilar products are available on the U.S. market, with more in the pipeline. These alternatives contain the same active ingredient as Humira, are approved by the FDA for the same indications, and offer potential savings of 5% to 85% depending on the product and payer. This guide covers what biosimilars are, which Humira biosimilars are approved, and how to evaluate whether switching makes sense for you.
What Is a Biosimilar?
A biosimilar is a biological product that is highly similar to an already-approved reference biologic (in this case, Humira) with no clinically meaningful differences in safety, purity, or potency. Unlike traditional generics, which are chemically identical copies of small-molecule drugs, biosimilars are derived from living organisms and are structurally complex proteins.
The FDA requires rigorous testing for biosimilar approval, including analytical studies comparing the biosimilar to the reference product, animal studies, and at least one clinical trial demonstrating equivalent efficacy and safety. Some biosimilars also achieve “interchangeable” status, meaning a pharmacist can substitute the biosimilar for the reference product without the prescriber’s explicit approval, similar to generic substitution.
According to the FDA, biosimilars are “just as safe and effective” as their reference biologics. The European Union has been using Humira biosimilars since 2018, providing years of real-world safety data that supports this conclusion.
FDA-Approved Humira Biosimilars
The following Humira biosimilar products have received FDA approval and are available or expected on the U.S. market. For a complete listing of all approved options, see our Humira biosimilar list.
Hadlima (adalimumab-bwwd) by Samsung Bioepis/Organon
FDA approved in July 2019. Launched in the U.S. in July 2023. Hadlima is designated as interchangeable with Humira, meaning pharmacists in most states can substitute it without a new prescription. Pricing is approximately 5% to 10% below Humira’s list price for the non-citrate-free formulation, with a citrate-free version also available.
Hyrimoz (adalimumab-adaz) by Sandoz
FDA approved in October 2018. U.S. launch occurred in July 2023. Hyrimoz is available in both citrate-free and standard formulations. Sandoz has positioned it competitively, with discounts ranging from 5% to 81% off Humira’s list price depending on the payer contract.
Amjevita (adalimumab-atto) by Amgen
FDA approved in September 2016 and launched in January 2023 as the first Humira biosimilar on the U.S. market. Amgen initially offered two pricing tiers: a list price roughly 5% below Humira and a lower list price approximately 55% below Humira. Amjevita has interchangeable status.
Cyltezo (adalimumab-adbm) by Boehringer Ingelheim
FDA approved in August 2017 and designated interchangeable in 2021, making it the first Humira biosimilar to earn interchangeable status. Cyltezo launched in the U.S. in July 2023 with a citrate-free formulation. Pricing discounts typically range from 5% to 80% off Humira’s list price.
Yusimry (adalimumab-aqvh) by Coherus BioSciences
FDA approved in December 2021. Launched in 2023. Coherus has targeted aggressive pricing, with discounts of up to 85% off Humira’s wholesale acquisition cost in some contracts.
Simlandi (adalimumab-ryvk) by Teva
FDA approved in March 2024 with interchangeable designation. Simlandi entered the market in the second half of 2024, adding to the growing competitive landscape.
How Much Can You Save With a Humira Biosimilar?
Savings depend on your insurance status, formulary placement, and which biosimilar is available through your plan.
Commercially insured patients: If your plan prefers a biosimilar over Humira, your copay may decrease, especially if the biosimilar is placed on a lower formulary tier. Some plans have moved Humira to a non-preferred tier to encourage biosimilar use, which means sticking with brand-name Humira could actually increase your cost.
Uninsured patients: At list price, some Humira biosimilars are available at $1,000 to $3,500 per month versus Humira’s list price of approximately $6,900 per month. Manufacturer discount programs for biosimilars can reduce costs further.
Medicare patients: Part D plans increasingly cover biosimilars at preferred tier status. Combined with the $2,000 annual out-of-pocket cap under the Inflation Reduction Act, the total annual cost for a Humira biosimilar under Medicare Part D is capped, providing certainty for beneficiaries. Extra Help recipients pay even less.
Is a Humira Biosimilar Right for You?
The decision to switch from Humira to a biosimilar should involve a conversation with your prescribing physician. Key considerations include:
Clinical equivalence: The FDA has determined that approved Humira biosimilars produce the same clinical outcomes as Humira. Studies published in journals including The Lancet and Annals of the Rheumatic Diseases confirm that switching from Humira to a biosimilar does not increase the risk of adverse events or reduce efficacy.
Injection experience: Some patients prefer citrate-free formulations because they cause less injection-site pain. Several Humira biosimilars are available in citrate-free versions. If injection comfort matters to you, ask about formulation options.
Insurance and formulary: Your plan’s formulary determines which product is most affordable for you. A biosimilar that is not on your plan’s preferred list may cost more than staying on Humira. Always check with your insurer before switching.
Support programs: Most biosimilar manufacturers offer copay assistance and patient support programs comparable to AbbVie’s Humira Complete program. Ask about nurse support, injection training, and savings cards.
Switching From Humira to a Biosimilar
If you decide to switch, the transition is straightforward. Because biosimilars have the same dosing and administration as Humira, you simply begin using the biosimilar at your next scheduled injection. There is no washout period, taper, or loading dose needed.
For interchangeable biosimilars, your pharmacist may be able to make the switch automatically, just as they would with a generic drug. State laws governing interchangeable biologics vary, and some require pharmacist notification to the prescriber. Your pharmacist can advise you on the rules in your state.
Monitor for any changes in how you feel after switching, and report them to your doctor. While the clinical data strongly supports seamless switching, individual monitoring remains good medical practice.
Frequently Asked Questions
Are Humira biosimilars as effective as Humira?
Yes. The FDA requires biosimilars to demonstrate no clinically meaningful differences in safety, purity, or potency compared to the reference product. Multiple clinical trials and years of real-world use in Europe confirm that Humira biosimilars perform equivalently to brand-name Humira.
Will my doctor need to write a new prescription?
For interchangeable biosimilars, a pharmacist can substitute at the pharmacy level without a new prescription in many states. For non-interchangeable biosimilars, your doctor will need to write a new prescription specifying the biosimilar product.
Do biosimilars have the same side effects as Humira?
The side effect profile of FDA-approved Humira biosimilars is the same as Humira. The most common side effects include injection site reactions, upper respiratory infections, and headache. Serious risks, including infections and malignancies, are the same as with Humira and are listed in the biosimilar’s prescribing information.
Can I switch back to Humira if the biosimilar does not work for me?
Yes. If you experience any issues after switching to a biosimilar, your doctor can switch you back to Humira. There is no medical barrier to re-starting the reference product.
Are there biosimilars for other biologics?
Yes. Biosimilars are available for several other reference biologics, including infliximab (Remicade), etanercept (Enbrel), rituximab (Rituxan), and bevacizumab (Avastin), among others. The biosimilar market continues to expand as more biologic patents expire.
Explore Your Biosimilar Options
A Humira biosimilar can deliver the same therapeutic benefit at a fraction of the cost. With multiple interchangeable options now on the market, patients have more choices than ever. Talk to your doctor about whether switching is right for you, check your insurance formulary for preferred products, and take advantage of manufacturer savings programs. For a detailed list of every approved option, visit our Humira biosimilar list. For broader cost-saving strategies, see our healthcare costs guide.