Humira Biosimilar List: Every FDA-Approved Adalimumab (2026)

The Complete List

Adalimumab — sold by AbbVie as Humira — was for years the best-selling drug in the world, peaking at roughly $21 billion in global sales before US biosimilar competition arrived in 2023. That made its patent cliff the single most-watched biosimilar event in the industry, and the resulting field of competitors is one of the deepest of any biologic.

Since the first approval in September 2016, the FDA has cleared ten adalimumab biosimilars. The first, Amjevita, could not launch until January 2023 because of a wall of AbbVie patents; most of the rest followed during 2023 under negotiated entry dates, and Simlandi, approved in February 2024, launched in May 2024. Below is the complete, verified roster — every brand, its nonproprietary name, manufacturer, FDA approval year, interchangeability status, and the formulation detail that, as it turned out, mattered more than any of the rest.

Every FDA-Approved Adalimumab Biosimilar

Approval years reflect the initial FDA biosimilar licensure; interchangeability dates, in most cases, came later, as listed in the FDA Purple Book (September 2026 update). “HC” denotes a high-concentration (100 mg/mL), citrate-free presentation; “LC” denotes the original low-concentration (50 mg/mL) format. Several products are available in both.

A note on naming: the FDA assigns each biosimilar a four-letter suffix appended to the core nonproprietary name (adalimumab) to distinguish products in pharmacovigilance. Those suffixes are meaningless to clinicians but useful for precisely identifying a product in a contract or a coverage policy — which is exactly where the money is decided.

What “Interchangeable” Means

A biosimilar is, by definition, highly similar to its reference product with no clinically meaningful differences. An interchangeable biosimilar is something narrower and more procedural: a product the FDA has additionally designated as eligible for pharmacy-level substitution without the prescriber being involved, much as a generic small molecule can be swapped for its brand. Historically that required extra data — often a switching study showing that alternating between the biosimilar and the reference product carried no added risk.

By 2026 the designation is no longer scarce. As of the FDA Purple Book’s September 2026 update, nine of the ten adalimumab biosimilars are interchangeable — Cyltezo (the first, in 2021), Abrilada (2023), Hyrimoz, Simlandi, Hadlima, and Amjevita (2024), Hulio and Yuflyma (2025), and Yusimry (August 2026) — leaving only Idacio without it. Designations have often been added presentation by presentation, so a product can be interchangeable in one concentration before another. For a payer or pharmacy, the practical value is automatic substitution, subject to state pharmacy law — but as the box below explains, that value is eroding.

High vs Low Concentration

The decisive technical variable in the Humira story was not interchangeability — it was concentration. The original Humira was a low-concentration (50 mg/mL) citrated formulation, and the first biosimilars matched that concentration. AbbVie later shifted the large majority of US Humira volume to a high-concentration (100 mg/mL), citrate-free version that halves the injection volume and stings less, because citrate is a known cause of injection-site pain.

That created a formulation mismatch. A biosimilar approved only in the low-concentration format is technically substitutable for old Humira but not for the version most patients were actually using. Pharmacists and prescribers were understandably reluctant to move a stable patient to a different concentration and a more painful shot. This is why high-concentration, citrate-free entrants — Yuflyma, Simlandi, Hadlima HC, Hyrimoz HC, and (since September 2026) Yusimry HC — are strategically better placed than their low-concentration peers, regardless of approval order.

The lesson generalizes well beyond adalimumab: a biosimilar must match the reference product’s currently dominant presentation, not merely its molecule. Device, concentration, and excipients are not packaging details; they are the difference between a launch that converts patients and one that sits on the shelf.

The 2023 Biosimilar War

When the negotiated entry dates arrived in 2023, the market saw something unprecedented: roughly eight or nine adalimumab biosimilars launching in a single year. The pricing strategies split into two camps. Some manufacturers offered a modest discount off Humira’s roughly $6,900-per-month list price while preserving rebate flexibility; others went for shock-and-awe list cuts.

Coherus priced Yusimry at about $995 per carton — an ~85% cut to list — and routed it through the Mark Cuban Cost Plus Drug Company, where it sold for a few hundred dollars plus fees. That looked like the future of transparent pricing. It was not. The low-list, low-rebate products struggled precisely because the system runs on rebates: a high list price funds the rebate that buys formulary position. A drug with almost no list price has almost no rebate to offer, and so could not buy its way onto the formularies that decide volume.

For most of 2023, the result was paradoxical. Nine approved competitors, real price cuts on offer — and biosimilar share stuck around 2–3%. AbbVie defended Humira with deep rebates that kept it preferred on formularies. The war was being fought, but the branded incumbent was winning it.

PBMs, Cordavis & Private Label

The logjam broke not because of a new drug but because of a new structure. In August 2023, CVS Health launched Cordavis, a subsidiary that contracts directly with manufacturers to co-commercialize private-label biosimilars. Its first product was a Cordavis-labeled version of Sandoz’s Hyrimoz, brought to market in early 2024 at a list price more than 80% below Humira’s.

Then came the formulary move. Effective April 1, 2024, CVS Caremark removed branded Humira from its major national commercial formularies in favor of biosimilars — steering volume to the Cordavis product. The effect was immediate: weekly new prescriptions for Sandoz’s Hyrimoz jumped from about 640 to almost 8,300 in the first week of April 2024. The other large PBMs followed with their own private-label arrangements (Express Scripts via Quallent, Optum Rx via Nuvaila) and removed branded Humira from their standard commercial formularies from January 2025.

This is the part of the Humira story that should command a dealmaker’s attention. The three big PBMs did not merely prefer a biosimilar; they became the de facto channel owner, putting their own label on the product and capturing the margin. For an asset originator, that means the buyer who matters most may not be a pharma company at all — it may be a vertically integrated PBM looking for supply. We explore the broader contracting dynamics in our biosimilars patent-cliff and licensing analysis.

The Market-Share Trajectory

The trajectory tells the whole story in three phases. Through 2023 and into early 2024, biosimilar adalimumab share sat in the low single digits (roughly 2–5%) despite the flood of launches. After the April 2024 PBM formulary changes, share climbed quickly as private-label products absorbed the bulk of the switch. After the January 2025 formulary changes at Express Scripts and Optum Rx, biosimilars moved past parity: Samsung Bioepis put adalimumab biosimilars at 60% of the US market as of February 2026, a figure that from 2026 includes Express Scripts’ Quallent private-label sales (CVS’s two Cordavis products are not counted), with branded Humira holding a shrinking share.

Two structural facts about that share are worth underlining for anyone modeling a biosimilar business. First, the private-label products captured the majority of the biosimilar volume — by several market-tracker estimates on the order of two-thirds, though exact figures vary by source and month — which means the economic winner of the Humira cliff was as much the PBM channel (CVS Cordavis, Optum/Nuvaila, Express Scripts/Quallent) as any individual manufacturer. Second, AbbVie itself blunted the damage by migrating patients to next-generation products (Skyrizi and Rinvoq), so the lost Humira revenue did not translate one-for-one into pain for the originator. A biosimilar can win share and still leave the incumbent healthier than expected.

For a dealmaker the implication is uncomfortable but clear: in a category where the PBM owns the channel and runs its own private label, a biosimilar developer can execute flawlessly on development and manufacturing and still capture little of the value, because the margin pools at the point of formulary control. Underwrite a biosimilar opportunity on the assumption that you are a supplier to a channel owner, not a brand competing on its own merits — and price the asset accordingly.

The BD & Licensing Read

The Humira episode is the closest thing the biosimilar industry has to a finished case study, and its lessons travel directly to the biologics now going through their own cliffs — Eylea (first US biosimilar launched in October 2024), Stelara (January 2025), Prolia (June 2025) — and to those still approaching them: the early checkpoint inhibitors and the first wave of biologics with expiring exclusivity later this decade. For a BD or licensing team, four takeaways carry the most weight:

• Match the dominant presentation, or lose. The single biggest predictor of a Humira biosimilar’s uptake was whether it shipped in the high-concentration, citrate-free format patients were already on. Diligence on a biosimilar asset must start with device and formulation, not the molecule.
• Channel access beats list price. The lowest-priced products did not win; the products that secured PBM formulary position — increasingly via private label — did. Underwrite the path to formulary, not the headline discount.
• Interchangeability is a depreciating asset. With the FDA flattening the distinction, paying a premium for a switching-study-backed label is increasingly poor value.
• The incumbent gets a vote — twice. AbbVie delayed entry for years through patents and then defended share through rebates and lifecycle migration. Any biosimilar model must price in a sophisticated originator’s defense, not assume a clean erosion curve.

For companies positioning around the next cliff, the deal structures that work are the same ones that worked here: well-timed entry agreements, supply deals with channel owners, and licensing terms that account for who actually captures the margin. That is the connective tissue between this list and the wider M&A and licensing wave we track in our 2026 biotech M&A and patent-cliff analysis, and the manufacturing economics we cover in our CDMO market analysis.

The next large class is following the same path: our Stelara biosimilar list covers all eight FDA-approved ustekinumab biosimilars, their makers, launch discounts and how quickly they are taking share.

The China Angle

Adalimumab is also a window into a quieter shift: who actually makes the world’s biosimilars. Several of the molecules and the manufacturing behind the global adalimumab field trace to Asian developers — Samsung Bioepis and Celltrion in Korea and Fujifilm Kyowa Kirin Biologics in Japan among them — often partnered with Western marketers for commercial reach. Chinese biosimilar makers, having first built scale in their large domestic market, are following the same path outward, pairing low-cost, high-quality manufacturing with Western distribution partners.

That has two consequences a cross-border dealmaker should hold in view. First, the supply of the next generation of biosimilars will be increasingly Asian-originated, which makes sourcing relationships in the region a genuine competitive advantage. Second, US reference pricing and most-favored-nation pressure on drug prices push in the same direction as the PBM private-label trend — toward the cheapest compliant supply — which is exactly where well-run Chinese and other Asian manufacturers compete. The originator of a biosimilar asset and the marketer who sells it are, more and more, on different continents. Structuring those partnerships is precisely the cross-border work we do; our out-licensing and strategic partnership teams build them.

Frequently Asked Questions

The Bottom Line

Ten FDA-approved adalimumab biosimilars, nine of them interchangeable, make Humira one of the most contested biosimilar markets ever — and the most instructive. The list itself is now stable; what moves is share, and share moved only when the channel structure changed. Formulation matching and PBM formulary access, not approval count or list price, decided the winners.

For anyone building toward the next patent cliff, the Humira playbook is the reference text: ship the right presentation, secure the channel, do not overpay for a fading interchangeability label, and respect the incumbent’s defense. If you are evaluating a biosimilar asset, a supply partnership, or an entry strategy for a biologic losing exclusivity, talk to our team.

Sources

1. Vision Lifesciences research: our own deal tracking and insights from our day-to-day cross-border licensing and M&A advisory work (about us)
2. US FDA, Purple Book: Database of Licensed Biological Products (adalimumab biosimilars and interchangeability dates, September 2026 update)
3. US FDA, interchangeability approval letter for Yusimry (adalimumab-aqvh) 40 mg/0.8 mL (August 2026)
4. US FDA, approval letter for Yusimry (adalimumab-aqvh) high-concentration interchangeable presentations (September 2026)
5. Meitheal Pharmaceuticals, FDA approval of high-concentration formulation of Yusimry (September 2026)
6. Coherus BioSciences, divestiture of Yusimry in a $40 million transaction (June 2024)
7. Teva and Alvotech, Simlandi (adalimumab-ryvk) now available in the US (May 2024)
8. Mylan and Fujifilm Kyowa Kirin Biologics, FDA approval of Hulio (July 2020)
9. Healio, CVS Caremark to replace Humira with biosimilars on national commercial formularies (January 2024)
10. BioSpace, Sandoz’s biosimilar skyrockets after CVS removes AbbVie’s Humira from formularies (April 2024)
11. Drug Channels, The Big Three PBMs’ 2025 formulary exclusions (April 2025)
12. Samsung Bioepis, press release on its Second Quarter 2026 US Biosimilar Market Report (April 2026)
13. Pharmaceutical Technology, AbbVie full-year 2022 net revenues (Humira $21.2 billion)
14. Big Molecule Watch, Amgen launches its aflibercept biosimilar in the US (November 2024)
15. Center for Biosimilars, Welcome Wezlana: the first Stelara biosimilar to launch in the US (January 2025)
16. The Pharma Letter, Sandoz launches first interchangeable denosumab biosimilars in the USA (June 2025)