Prescription medicine
Adalimumab-ryvk Brand names: Simlandi
Adalimumab-ryvk (Simlandi) is a prescription medicine with an FDA approval on record since 2024. No generic is listed; pharmacies paid $499.12 per unit (Simlandi(cf) 40 mg/0.4 mL autoinjector) in the October 7, 2026 NADAC survey.
- No generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the adalimumab-ryvk FDA label on DailyMed (effective October 31, 2025, Teva Pharmaceuticals USA, Inc.); the BLA 761299 record on Drugs@FDA; every adalimumab-ryvk label on DailyMed.
Highlights of the record
FDA label of October 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including SIMLANDI, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) ]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue SIMLANDI if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before SIMLANDI use and during therapy. Initiate treatment for latent TB prior to SIMLANDI use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria. […]
Used for
From the label: indications and usageSIMLANDI 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.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- February 23, 2024 Simlandi, Alvotech Usa Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 3 of which 0 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $499.12 per unit Simlandi(cf) 40 mg/0.4 mL autoinjector
- Shortage (FDA)
- None current 1 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 914 through July 30, 2026
What is adalimumab-ryvk used for?
From the label: indications and usageSIMLANDI 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. ( 1.1 ) Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. ( 1.3 ) Reducing signs and symptoms in adult patients with active ankylosing spondylitis. […]
Conditions named in the indications of adalimumab-ryvk's FDA labels, with every medicine labeled for each:
From other adalimumab-ryvk labelsPsoriasis: Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. …
Rheumatoid arthritis: Rheumatoid Arthritis SIMLANDI is 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 …
Crohn's disease and ulcerative colitis: Crohn’s Disease SIMLANDI is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
Source: FDA drug label (Simlandi), BLA761299 (Alvotech Usa Inc), as published by Teva Pharmaceuticals USA, Inc., effective October 31, 2025 (SPL set 12f609c9-2088-bb05-e063-6394a90a9ecc), via openFDA; the full label on DailyMed
What does the patient leaflet for adalimumab-ryvk say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SIMLANDI?SIMLANDI is a medicine that affects your immune system. SIMLANDI can lower the ability of your immune system to fight infections. Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting SIMLANDI. Your doctor should check you closely for signs and symptoms of TB during treatment with SIMLANDI. You should not start taking SIMLANDI if you have any kind of infection unless your doctor says it is okay. Before starting SIMLANDI, tell your doctor if you: think you have an infection or have symptoms of an infection such as: fever, sweats, or chills muscle aches cough shortness of breath blood in phlegm warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal feel very tired weight loss are being treated for an infection. get a lot of infections or have infections that keep coming back. have diabetes. have TB, or have been in close contact with someone with TB. were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your doctor if you are not sure. live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use SIMLANDI. […]
From the patient leaflet: How should I store SIMLANDI ?Store SIMLANDI in the refrigerator at 36°F to 46°F (2°C to 8°C). Store SIMLANDI in the original carton until use to protect it from light. Do not freeze SIMLANDI . Do not use SIMLANDI if frozen, even if it has been thawed. Refrigerated SIMLANDI may be used until the expiration date printed on the SIMLANDI carton, dose tray, autoinjector or prefilled syringe. Do not use SIMLANDI after the expiration date. If needed, for example when you are traveling, you may also store SIMLANDI at room temperature up to 77°F (25°C) for up to 30 days. Store SIMLANDI in the original carton until use to protect it from light. Throw away SIMLANDI if it has been kept at room temperature and not been used within 30 days. Record the date you first remove SIMLANDI from the refrigerator on the carton and dose tray. Do not store SIMLANDI in extreme heat or cold. […]
Source: FDA drug label (Simlandi), BLA761299 (Alvotech Usa Inc), as published by Teva Pharmaceuticals USA, Inc., effective October 31, 2025 (SPL set 12f609c9-2088-bb05-e063-6394a90a9ecc), via openFDA; the full label on DailyMed
Is there a generic for adalimumab-ryvk (Simlandi)?
No generic adalimumab-ryvk is approved (Drugs@FDA, October 8, 2026).
- 2024 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for adalimumab-ryvk (Simlandi)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $499.12 per unit (Simlandi(cf) 40 mg/0.4 mL autoinjector), up 3% from $482.88 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Simlandi(cf) 40 mg/0.4 mL autoinjector (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Simlandi(cf) 40 mg/0.4 mL autoinjector | Brand | $499.12 per unit | n/a | +3% |
| Simlandi(cf) 40 mg/0.4 mL syringe | Brand | $478.65 per syringe | n/a | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is adalimumab-ryvk in shortage?
No adalimumab-ryvk presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 1 record is all marked to be discontinued, the latest updated November 13, 2025. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Simlandi, Kit, Kit (NDC 51759-523-21) | Teva Pharmaceuticals USA, Inc. | To Be Discontinued | November 13, 2025 |
Every adalimumab-ryvk presentation in the FDA shortage database
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the adalimumab-ryvk label say about other medicines?
The adalimumab-ryvk label names 9 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Abatacept | drug interactions | DRUG INTERACTIONS Abatacept: Increased risk of serious infection. |
| Adalimumab | boxed warning | SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including SIMLANDI, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) ]. |
| Anakinra | drug interactions | In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of SIMLANDI with abatacept or anakinra is not recommended in patients with RA [see Warnings and Precautions ( 5.7 … |
| Azathioprine | boxed warning | Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. |
| Cyclosporine | drug interactions | Upon initiation or discontinuation of SIMLANDI in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. |
| Methotrexate | boxed warning | Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. |
| Rituximab | drug interactions | A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. |
| Theophylline | drug interactions | Upon initiation or discontinuation of SIMLANDI in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. |
| Warfarin | drug interactions | Upon initiation or discontinuation of SIMLANDI in patients being treated with CYP450 substrates with a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or drug concentration (e.g., cyclosporine or theophylline) is recommended and the individual dose of the drug product may be adjusted as needed. |
Source: FDA drug label (Simlandi), BLA761299 (Alvotech Usa Inc), as published by Teva Pharmaceuticals USA, Inc., effective October 31, 2025 (SPL set 12f609c9-2088-bb05-e063-6394a90a9ecc), via openFDA; the full label on DailyMed
What do FAERS reports show for adalimumab-ryvk?
The FDA Adverse Event Reporting System holds 914 reports that list adalimumab-ryvk among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 72 are coded as a death and 233 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as adalimumab-ryvk?
12 other medicines are given the same way (subcutaneous) and in the same FDA class as adalimumab-ryvk or labeled mainly for the same use (psoriasis), the same class first. Psoriasis lists all 38 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Adalimumab | Rheumatoid arthritis, Crohn's disease and ulcerative colitis, Psoriasis | none listed | $1,587.82 per mL 40 mg/0.4 mL | No current entry |
| Methotrexate | Rheumatoid arthritis, Psoriasis | none listed | $289.37 per mL 25 mg/0.5 mL autoinj | In shortage |
| Etanercept | Rheumatoid arthritis, Psoriasis | none listed | $2,084.14 per mL 25 mg/0.5 mL syringe | No current entry |
| Risankizumab | Crohn's disease and ulcerative colitis, Psoriasis | none listed | $22,774.36 per mL 150 mg/mL pen | No current entry |
| Bimekizumab | Psoriasis | none listed | $8,073.83 per mL 160 mg/mL autoinjector | No current entry |
| Ixekizumab | Psoriasis | none listed | $7,370.72 per mL 80 mg/mL autoinjector | No current entry |
| Secukinumab | Psoriasis | none listed | $3,946.35 per mL 300 mg dose/2 pens (150 mg/pen) | No current entry |
| Spesolimab | Psoriasis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as adalimumab-ryvk
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to adalimumab-ryvk
- 12 medicines for the same use
- Adalimumab-ryvk side effects
- the label's list beside FAERS reports
- Adalimumab-ryvk shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other