For nearly two decades, Humira (adalimumab) was the best-selling drug in the world, generating hundreds of billions of dollars in lifetime revenue for AbbVie. With list prices that ran into the tens of thousands of dollars per patient per year, Humira represented both a medical breakthrough for autoimmune diseases and a major cost burden for patients and the healthcare system. The launch of Humira biosimilar products in the United States, beginning in January 2023, marked a turning point that has brought real competition and cost relief. This article is independent, educational information — FMHC is not affiliated with AbbVie or any biosimilar manufacturer, and nothing here is medical advice.
As of 2026, roughly ten Humira biosimilar products have FDA approval, and many patients have already been moved onto them by their health plans. These alternatives contain the same active ingredient as Humira, are FDA-approved for the same indications, and can offer meaningful savings depending on the product and payer. This guide covers what biosimilars are, which Humira biosimilars are approved, how formulations differ, and how to think about 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 made from living cells and are large, structurally complex proteins that cannot be copied exactly. For a fuller primer, see our overview of what biosimilars are.
The FDA requires rigorous testing for biosimilar approval, including extensive analytical characterization comparing the biosimilar to the reference product and clinical studies demonstrating equivalent efficacy and safety. Some biosimilars also earn an “interchangeable” designation — a separate, additional FDA status that can, in some states, allow a pharmacist to substitute the biosimilar for the reference product without a new prescription, similar to generic substitution. According to the FDA, biosimilars are just as safe and effective as their reference biologics. The European Union has used adalimumab biosimilars since 2018, providing years of real-world safety data that supports this conclusion.
FDA-Approved Humira Biosimilars
There are now roughly ten FDA-approved Humira biosimilar products. For a complete, regularly updated listing, see our Humira biosimilar list, and verify current approvals in the FDA’s Purple Book. The approved adalimumab biosimilars include:
- Amjevita (adalimumab-atto) — Amgen; FDA approved September 2016 and launched in January 2023 as the first Humira biosimilar on the U.S. market.
- Cyltezo (adalimumab-adbm) — Boehringer Ingelheim; approved August 2017 and designated interchangeable in 2021, the first Humira biosimilar to earn that status. Launched July 2023.
- Hyrimoz (adalimumab-adaz) — Sandoz; approved October 2018, launched July 2023, available in citrate-free and standard formulations.
- Hadlima (adalimumab-bwwd) — Samsung Bioepis/Organon; approved July 2019, launched July 2023, offered in citrate-free and standard versions.
- Abrilada (adalimumab-afzb) — Pfizer; approved November 2019.
- Hulio (adalimumab-fkjp) — approved July 2020.
- Yusimry (adalimumab-aqvh) — Coherus BioSciences; approved December 2021 and known for aggressive low-cash-price positioning.
- Idacio (adalimumab-aacf) — Fresenius Kabi; approved December 2022.
- Yuflyma (adalimumab-aaty) — Celltrion; approved May 2023, a high-concentration, citrate-free formulation.
- Simlandi (adalimumab-ryvk) — Alvotech/Teva; approved February 2024 and designated interchangeable, a high-concentration citrate-free option.
Several products (including Cyltezo and Simlandi) carry an interchangeability designation, and additional biosimilars have sought or may gain that status over time. Because interchangeability and market availability can change, verify the current designation and availability of any specific product in the FDA Purple Book and with your pharmacy.
Concentration and Citrate-Free Formulations
Two formulation details matter when comparing options. First, concentration: adalimumab is available in high-concentration (typically 100 mg/mL) and lower-concentration (about 50 mg/mL) versions. High-concentration products deliver the dose in a smaller injection volume, which many patients find more comfortable, and the majority of the U.S. Humira market moved to high concentration before biosimilars launched. Matching your prescription to a high- or low-concentration biosimilar can matter for a smooth switch.
Second, citrate content: some formulations are “citrate-free.” Citrate is a buffer historically associated with stinging or burning at the injection site, so citrate-free versions are often described as more comfortable to inject. Several Humira biosimilars are available citrate-free. If injection comfort matters to you, ask your prescriber and pharmacist which concentration and citrate status your product is, and whether a citrate-free high-concentration option is available on your plan.
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. Treat all dollar figures below as estimates that change over time — verify current pricing with your plan and pharmacy.
Commercially insured patients: If your plan prefers a biosimilar over Humira, your copay may be lower, especially when the biosimilar sits on a lower formulary tier. Since 2024, several large pharmacy benefit managers and health plans have moved Humira to non-preferred status or removed it from formularies, shifting many patients onto biosimilars — which means staying on brand Humira could now cost more, or not be covered at all.
Uninsured or cash-pay patients: At cash or list price, some Humira biosimilars have been offered well below Humira’s list price — in some cases around $1,000 to $3,500 per month, and certain low-cost cash options have been priced even lower — versus a Humira list price that has run roughly $6,000 to $7,000+ per month. Manufacturer discount programs can reduce costs further.
Medicare patients: Part D plans increasingly cover biosimilars at preferred tiers. Combined with the $2,000 annual out-of-pocket cap on Part D drug spending that took effect in 2025 under the Inflation Reduction Act, the total annual out-of-pocket cost for a Humira biosimilar under Part D is now capped, providing more predictability. Extra Help recipients typically pay even less.
Patient Assistance and Manufacturer Programs
Most biosimilar manufacturers offer copay assistance and patient support programs comparable to AbbVie’s Humira Complete. Ask about copay cards (for eligible commercially insured patients), free-drug programs for those who qualify by income, nurse support, and injection training. Note that AbbVie’s patient assistance for brand Humira has been changing: reports indicate that myAbbVie Assist is set to stop accepting new Humira patients around mid-2026, so if you rely on that program, verify current eligibility and timing directly with the program and explore biosimilar assistance options. See our overview of the AbbVie patient assistance program for context, and confirm any dates before relying on them.
Is a Humira Biosimilar Right for You?
The decision to start on, or switch to, a biosimilar is a clinical one to make 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 such as The Lancet and Annals of the Rheumatic Diseases have found that switching from Humira to a biosimilar does not increase adverse events or reduce efficacy.
Injection experience: As noted above, some patients prefer citrate-free and/or high-concentration formulations for comfort. Ask about the options available to you.
Insurance and formulary: Your plan’s formulary largely determines which product is most affordable. A biosimilar that is not on your plan’s preferred list may cost more than the preferred one, so always check with your insurer before switching. Understanding the role of your pharmacy benefit manager (PBM) can help explain why your plan prefers a particular product.
Support programs: Compare the assistance programs across manufacturers, since copay support, free-drug eligibility, and nurse services vary.
Switching From Humira to a Biosimilar
If you and your prescriber decide to switch, the transition is generally straightforward. Because biosimilars have the same dosing and administration as Humira, you begin using the biosimilar at your next scheduled injection — there is no washout period, taper, or loading dose. Matching the concentration and citrate status of your previous product helps keep the injection experience consistent.
For interchangeable biosimilars, a pharmacist may be able to make the switch at the pharmacy level, much like a generic substitution. State laws governing interchangeable biologics vary, and some require the pharmacist to notify the prescriber. Your pharmacist can explain the rules in your state.
Monitor how you feel after switching and report any changes to your doctor. While the clinical data strongly supports seamless switching, individual monitoring remains good medical practice, and adalimumab in any form requires ongoing clinical oversight.
Frequently Asked Questions
How many Humira biosimilars are there?
Roughly ten adalimumab biosimilars have FDA approval, including Amjevita, Cyltezo, Hyrimoz, Hadlima, Abrilada, Hulio, Yusimry, Idacio, Yuflyma, and Simlandi. Availability and coverage vary by plan, so confirm current options with your prescriber and pharmacy, and check the FDA Purple Book.
Are Humira biosimilars as effective as Humira?
Yes. The FDA requires biosimilars to show no clinically meaningful differences in safety, purity, or potency compared with the reference product. Multiple clinical trials and years of real-world use in Europe confirm that adalimumab biosimilars perform equivalently to brand-name Humira.
Which Humira biosimilars are interchangeable?
Cyltezo was the first Humira biosimilar designated interchangeable (2021), and Simlandi is also interchangeable. Interchangeability is a separate FDA designation that can allow pharmacy-level substitution in some states, and additional products may gain it over time — verify the current status of any specific product in the FDA Purple Book.
Do biosimilars have the same side effects as Humira?
The safety profile of FDA-approved Humira biosimilars matches Humira’s. Common side effects include injection-site reactions, upper respiratory infections, and headache. Serious risks — including serious infections and malignancies (Humira and its biosimilars carry a boxed warning) — are the same and are listed in each product’s prescribing information. This is not a self-managed medication; use it under a clinician’s supervision.
Can I switch back to Humira if a biosimilar does not work for me?
Yes. If you have issues after switching, your prescriber can switch you back to Humira or to a different biosimilar; there is no medical barrier to changing products, though coverage will depend on your plan.
Explore Your Biosimilar Options
A Humira biosimilar can deliver the same therapeutic benefit at a lower cost, and with about ten FDA-approved options — several interchangeable and several citrate-free — patients have more choices than ever. Talk to your prescriber about whether switching is right for you, check your plan’s formulary for preferred products and confirm the concentration and citrate status, and take advantage of manufacturer savings programs. For a detailed listing, visit our Humira biosimilar list and companion biosimilar Humira overview; for broader strategies, see our healthcare costs guide.
TL;DR: Humira (adalimumab) now has about ten FDA-approved biosimilars — Amjevita, Cyltezo, Hyrimoz, Hadlima, Abrilada, Hulio, Yusimry, Idacio, Yuflyma, and Simlandi — several launched in 2023, with more shifts driven by 2024 formulary changes. They meet the same FDA standards for safety and effectiveness and can cost less. Some (Cyltezo, Simlandi) are interchangeable; formulations differ by concentration and citrate content. Starting or switching is a clinical decision with your prescriber — check your plan’s formulary and manufacturer assistance, and verify current approvals, interchangeability, and prices.
Medical disclaimer: This article is independent, educational information and not medical advice. FMHC is not affiliated with AbbVie or any biosimilar manufacturer. Approvals, interchangeability status, program dates, and prices change — verify current details with the FDA and your care team, and make treatment decisions with your prescriber.
Sources
- U.S. Food & Drug Administration — Biosimilar Product Information (approved adalimumab biosimilars)
- FDA — Purple Book (licensed biological products, including interchangeability status)
- FDA — Biosimilar and Interchangeable Biologics: More Treatment Choices
- MedlinePlus (U.S. National Library of Medicine) — Adalimumab Injection
- Manufacturer patient assistance programs — myAbbVie Assist and biosimilar-maker copay/assistance programs (verify current eligibility and dates)