Quick answers
- What is Adalimumab-atto used for?
- The FDA-approved label (Amjevita, Amgen USA Inc., July 13, 2026) says: “AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Adalimumab-atto have a boxed warning?
- Yes. The FDA label for Amjevita has a boxed warning (“WARNING: SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Adalimumab-atto?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated January 13, 2026). Ask your pharmacist about alternatives.
- Has Adalimumab-atto been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started October 10, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Adalimumab-atto?
- 9 companies list prescription products of Adalimumab-atto in the FDA NDC Directory, including Cordavis Limited, Amgen, Inc and Sandoz Inc.
What Adalimumab-atto is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. …
— FDA label: Amjevita, Amgen USA Inc., effective July 13, 2026. Read the full label on DailyMed →
The FDA has 10 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY
. Read it on the full label →
10 of 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| adalimumab 40 mg/0.4 mL injection, solution | Generic | $1,589.40 per mL |
| adalimumab 40 mg/0.4 mL solution | Brand: Hadlima | $1,258.09–$1,259.45 per mL 2 packages, lowest to highest |
| adalimumab 40 mg/0.8 mL solution | Brand: Hadlima | $617.14–$632.97 per mL 2 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Cordavis Limited9 products
- Amgen, Inc9 products
- Sandoz Inc8 products
- Amgen USA Inc.5 products
- Organon LLC5 products
- Meitheal Pharmaceuticals Inc.4 products
- Nuvaila Limited4 products
- A-S Medication Solutions4 products
- Coherus BioSciences Inc2 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761024 AMJEVITA | Amgen Inc | September 23, 2016 | 12, latest October 16, 2025 2025: BIOSIMILAR · 2025: Labeling · 2025: Efficacy |
| BLA761059 HADLIMA | Samsung Bioepis Co Ltd | July 23, 2019 | 12, latest April 29, 2026 2026: Manufacturing (CMC) · 2025: Manufacturing (CMC) · 2025: Labeling |
| BLA761071 HYRIMOZ | Sandoz Inc | October 30, 2018 | 12, latest October 16, 2025 2025: BIOSIMILAR · 2025: Labeling · 2025: Supplement |
| BLA761216 YUSIMRY | Emerge Bioscience Pte Ltd | December 17, 2021 | 6, latest September 25, 2026 2026: BIOSIMILAR · 2026: Labeling · 2025: BIOSIMILAR |
Shortage status
To be discontinued · updated January 13, 2026 · first posted January 13, 2026
| Product | Hyrimoz, Injection, 40 mg/.4 mL (NDC 61314-473-64) |
|---|---|
| Company | Sandoz Inc. |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
October 10, 2025 · Class II · Ongoing · D-0099-2026
Lack of Assurance of Sterility.
HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured by: SAMSUN BIOEPIS — Samsung Bioepis Co., Ltd.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Amjevita, Amgen USA Inc., effective July 13, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →