SIMLANDI^® is the
first and only
FDA-approved biosimilar interchangeable for the most widely prescribed Humira^® formulation^1,2*^†

*The most widely prescribed formulation of Humira is high concentration and citrate free (40 mg/0.4 mL).²

^†SIMLANDI is interchangeable for the indications of use, dosage forms, strengths, and routes of administration described in the Prescribing Information.

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SIMLANDI DOSING

Indication

Ankylosing spondylitis: SIMLANDI is indicated
for reducing signs and symptoms in adult
patients with active ankylosing spondylitis.

Recommended dosage^3‡

SIMLANDI Autoinjector
40 mg/0.4 mL

40 mg every other week

^‡Methotrexate, other nonbiologic disease-modifying antirheumatic drugs, glucocorticoids, nonsteroidal anti-inflammatory drugs, and/or
analgesics may be continued during treatment with SIMLANDI.

See SIMLANDI savings & support

Indication

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.

Recommended dosage^3§

SIMLANDI Autoinjector
40 mg/0.4 mL

Day 1^||

160 mg (4 x 40 mg)

Day 15

80 mg (2 x 40 mg)

^§Aminosalicylates and/or corticosteroids may be continued
during treatment with SIMLANDI. Azathioprine, 6-
mercaptopurine, or methotrexate may be continued
during treatment with SIMLANDI if necessary.

^||Administer as four 40-mg injections in 1 day or as two
40-mg injections per day for 2 consecutive days.

Starting Day 29

40 mg every other week

^¶Aminosalicylates and/or corticosteroids may be continued during treatment with SIMLANDI. Azathioprine, 6-mercaptopurine, or methotrexate may be continued
during treatment with SIMLANDI if necessary.

See SIMLANDI savings & support

Indication

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.

Recommended dosage³

In patients 6 years of age and older and 40 kg (88 lb) and greater^#

SIMLANDI Autoinjector
40 mg/0.4 mL

Day 1**

160 mg (4 x 40 mg)

Day 15

80 mg (2 x 40 mg)

^#There is no dosage form of SIMLANDI that allows weight-based dosing for pediatric patients below 40 kg.

**Administer as four 40-mg injections in 1 day or as two 40-mg injections per day for 2 consecutive days.

Starting Day 29

40 mg every other week

^††There is no dosage form of SIMLANDI that allows weight-based dosing for pediatric patients below 40 kg.

See SIMLANDI savings & support

Indication

Hidradenitis suppurativa: SIMLANDI is
indicated for the treatment of moderate to
severe hidradenitis suppurativa in adult patients.

Recommended dosage³

SIMLANDI Autoinjector
40 mg/0.4 mL

Day 1^‡‡

160 mg (4 x 40 mg)

Day 15

80 mg (2 x 40 mg)

^‡‡Administer as four 40-mg injections in 1 day or as two
40-mg injections per day for 2 consecutive days.

Starting Day 29

40 mg weekly

80 mg (2 x 40 mg) every other week

See SIMLANDI savings & support

Indication

Juvenile idiopathic arthritis: SIMLANDI is indicated, alone or in combination with methotrexate, for reducing signs and
symptoms
of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

Recommended dosage^3§§

In patients 2 years of age or older and 30 kg
(66 lb) and greater^||||

SIMLANDI Autoinjector
40 mg/0.4 mL

40 mg every other week

^§§Methotrexate, glucocorticoids, nonsteroidal anti-
inflammatory drugs, and/or analgesics may be continued
during treatment with SIMLANDI.

^||||There is no dosage form of SIMLANDI that allows weight-
based dosing for pediatric patients below 30 kg.

See SIMLANDI savings & support

Indication

Plaque psoriasis: SIMLANDI is indicated for the 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. SIMLANDI should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Recommended dosage³

SIMLANDI Autoinjector
40 mg/0.4 mL

Day 1

80 mg (2 x 40 mg)

Starting Day 8

40 mg every other week

The use of adalimumab products in moderate to severe chronic plaque psoriasis beyond 1 year has not been evaluated in controlled clinical studies.

See SIMLANDI savings & support

Indication

Psoriatic arthritis: SIMLANDI is indicated, alone or in combination with non-biologic disease-modifying anti-rheumatic drugs (DMARDs), for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.

Recommended dosage^3¶¶

SIMLANDI Autoinjector
40 mg/0.4 mL

40 mg every other week

^¶¶Methotrexate, other nonbiologic DMARDs,
glucocorticoids, nonsteroidal anti-inflammatory drugs,
and/or analgesics may be
continued during treatment
with SIMLANDI.

See SIMLANDI savings & support

Indication

Rheumatoid arthritis: SIMLANDI is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs), 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.

Recommended dosage^3##

SIMLANDI Autoinjector
40 mg/0.4 mL

40 mg every other week

^##Methotrexate (MTX), other nonbiologic DMARDs, glucocorticoids, nonsteroidal anti-inflammatory drugs, and/or analgesics may be continued during treatment
with SIMLANDI. Some patients not taking concomitant MTX may derive additional benefit from increasing the dosage of SIMLANDI to 40 mg every week or 80 mg
every other week.

See SIMLANDI savings & support

Indication

Ulcerative colitis: SIMLANDI is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.

Limitations of Use: The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.

Recommended dosage^3‡‡‡³***

SIMLANDI Autoinjector
40 mg/0.4 mL

Day 1^†††

160 mg (4 x 40 mg)

Day 15

80 mg (2 x 40 mg)

***Discontinue SIMLANDI in adult patients without evidence of clinical remission by 8 weeks (Day 57) of therapy.
Aminosalicylates and/or corticosteroids may be
continued
during treatment with SIMLANDI. Azathioprine and 6-mercaptopurine may be continued during treatment with SIMLANDI if necessary.

^†††Administer as four 40-mg injections in 1 day or as two
40-mg injections per day for 2 consecutive days.

Starting Day 29

40 mg every other week

^‡‡‡Discontinue SIMLANDI in adult patients without evidence of clinical remission by 8 weeks (Day 57) of therapy.
Aminosalicylates and/or corticosteroids may be
continued
during treatment with SIMLANDI. Azathioprine and 6-mercaptopurine may be continued during treatment with SIMLANDI if necessary.

See SIMLANDI savings & support

Indication

Uveitis: SIMLANDI is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

Recommended dosage³

SIMLANDI Autoinjector
40 mg/0.4 mL

Day 1

80 mg (2 x 40 mg)

Starting Day 8

40 mg every other week

See SIMLANDI savings & support

Administration considerations³

SIMLANDI is administered by subcutaneous injection
The first injection should be given under the supervision of a healthcare professional. A patient may self-inject SIMLANDI after appropriate training and monitoring by a healthcare professional
Prior to initiating SIMLANDI and periodically during therapy, patients should be evaluated for active tuberculosis and tested for latent infection
SIMLANDI can be taken out of the refrigerator for 15 to 30 minutes before injecting to allow the liquid to come to room temperature. Do not remove the cap or cover while allowing it to reach room temperature. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulates and discolorations are noted, do not use the product. SIMLANDI does not contain preservatives; therefore, discard unused portions of drug remaining from the autoinjector
Instruct patients using the SIMLANDI autoinjector to inject the full amount in the syringe, according to the directions provided in the Instructions for Use
Injections should occur at separate sites in the thigh or abdomen. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red, or hard
If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time

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. 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 pulmonary or extrapulmonary disease. Evaluate patients for tuberculosis risk factors and test for latent TB before initiating SIMLANDI and periodically 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.

Carefully consider the risks and benefits of treatment with SIMLANDI prior to initiating therapy in patients: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with SIMLANDI, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

Do not start SIMLANDI during an active infection, including localized infections.
Patients 65 years of age and older, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants, may be at greater risk of infection.
If an infection develops, monitor carefully and initiate appropriate therapy.
Drug interactions with biologic products: A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of SIMLANDI with other biologic DMARDs (e.g., anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6-MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants.

Consider the risks and benefits of TNF blocker-treatment, including SIMLANDI, prior to initiating therapy in patients with known malignancy.
Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or PUVA therapy for the presence of NMSC prior to and during treatment with SIMLANDI.
In the adalimumab clinical trials there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk than the general population for the development of lymphoma, even in the absence of TNF blockers.
Postmarketing cases of acute and chronic leukemia have been reported in association with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases represented a variety of different malignancies and included rare malignancies associated with immunosuppression and malignancies that are not usually observed in children and adolescents.

Hypersensitivity Reactions

Anaphylaxis or serious allergic reactions have been reported following administration of adalimumab products. If an anaphylactic or other serious hypersensitivity reaction occurs, immediately discontinue administration of SIMLANDI and institute appropriate therapy.

Hepatitis B Virus Reactivation

Use of TNF blockers, including SIMLANDI, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases with HBV reactivation occurring in conjunction with TNF blocker therapy have been fatal.
Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy.
Exercise caution in patients identified as carriers of HBV and closely monitor during and after SIMLANDI treatment.
In patients who develop HBV reactivation, stop SIMLANDI and initiate effective anti-viral therapy. Exercise caution when resuming SIMLANDI after HBV treatment.

Neurologic Reactions

Use of TNF blocking agents, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating disease, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
Exercise caution when considering SIMLANDI for patients with these disorders; discontinuation of SIMLANDI should be considered if any of these disorders develop.
There is a known association between intermediate uveitis and central demyelinating disorders.

Hematological Reactions

Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blocking agents. Medically significant cytopenia has been infrequently reported with adalimumab products.
Advise patients to seek medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor).
Consider stopping SIMLANDI if significant hematologic abnormalities occur.

Heart Failure

Worsening and new onset congestive heart failure (CHF) have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products; exercise caution when using SIMLANDI in patients who have heart failure and monitor them carefully.

Autoimmunity

Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

Immunizations

Patients on SIMLANDI should not receive live vaccines.
Pediatric patients, if possible, should be brought up to date with all immunizations prior to initiating SIMLANDI therapy.
Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants.

ADVERSE REACTIONS

The most common adverse reactions (greater than or equal to 10%): are infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.

SIMLANDI^® (adalimumab-ryvk) injection, is a tumor necrosis factor (TNF)-blocker indicated for:

Rheumatoid Arthritis (RA): Alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs), 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 RA.
Juvenile Idiopathic Arthritis (JIA): Alone or in combination with methotrexate for reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
Psoriatic Arthritis (PsA): Alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS.
Crohn’s Disease (CD): Treatment of moderately to severely active CD in adults and pediatric patients 6 years of age and older.
Ulcerative Colitis (UC): Treatment of moderately to severely active UC in adult patients.
Limitations of use: The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.
Plaque Psoriasis (Ps): The treatment of adult patients with moderate to severe chronic Ps who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. SIMLANDI should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
Hidradenitis Suppurativa (HS): The treatment of moderate to severe HS in adult patients.
Uveitis: The treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for SIMLANDI, including BOXED WARNINGS.

References:

1. Alvotech and Teva announce U.S. approval of SIMLANDI^® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira^®. News release. Alvotech USA Inc. Accessed February 23, 2024. https://investors.alvotech.com/news-releases/news-release-details/alvotech-and-teva-announce-us-approval-simlandir-adalimumab-ryvk 2. Data on file. Parsippany, NJ. Teva Pharmaceuticals. 3. SIMLANDI^® (adalimumab-ryvk) injection. Current Prescribing information. Leesburg, VA: Alvotech USA Inc.

SIMLANDI® is the first and onlyFDA-approved biosimilar interchangeable for the most widely prescribed Humira® formulation1,2*†

SIMLANDI DOSING

Administration considerations3

References:

SIMLANDI^® is the
first and only
FDA-approved biosimilar interchangeable for the most widely prescribed Humira^® formulation^1,2*^†

Administration considerations³