Is Hulio (adalimumab) the same as Humira (adalimumab)?

Hulio (adalimumab) is a biosimilar to Humira (adalimumab). This means it has a comparable structure and [works similarly](https://www.fda.gov/drugs/biosimilars/basics-patients) to Humira, the original medication approved by the FDA. Biosimilars are like generics, but they're not exactly the same as the original [biologic](https://www.goodrx.com/healthcare-access/medication-education/biologics-biological-drugs-examples#:~:text=What%20are%20biological%20drugs). Compared to Hulio (adalimumab), Humira (adalimumab) is additionally FDA approved to treat [uveitis](https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/uveitis) (inflammation in the middle layer of the eye) for children and adults, but Hulio (adalimumab) is only approved to treat that condition in adults.

How does Hulio (adalimumab) compare to Humira (adalimumab) for treating rheumatoid arthritis?

In a [clinical study](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6909638/), researchers found that Hulio (adalimumab) worked just as well as Humira (adalimumab) for treating rheumatoid arthritis. They also found that it had similar side effects.

Hulio

Used for Ankylosing Spondylitis, Crohn's Disease, Hidradenitis Suppurativa, Juvenile Idiopathic Arthritis, Plaque Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis, Uveitis

Hulio (adalimumab or adalimumab-fkjp) is an injection used to treat several autoimmune conditions (e.g., certain types of arthritis, ulcerative colitis, Crohn's disease, and plaque psoriasis). It's a biosimilar to Humira (adalimumab), but it's not FDA approved for all age groups within a condition. Hulio (adalimumab) is expected to be available in the United States in July 2023.

Reviewed by:

Kristianne Hannemann, PharmD

Daisy Chau, PharmD

Last reviewed on December 22, 2022

What is Hulio (adalimumab)?

What is Hulio (adalimumab) used for?

Rheumatoid arthritis (RA) - adults only
Juvenile idiopathic arthritis (JIA) - people age 2 and older
Psoriatic arthritis (PsA) - adults only
Ankylosing spondylitis (AS) - adults only
Crohn's disease (CD) - people age 6 and older
Ulcerative colitis (UC) - adults only
Plaque psoriasis - adults only
Hidradenitis suppurativa - adults only
Uveitis - adults only

How Hulio (adalimumab) works

Hulio (adalimumab) is a biologic disease-modifying antirheumatic drug (DMARD). It works by blocking tumor necrosis factor (TNF), a protein in your body that plays a role in inflammation. By blocking TNF, Hulio (adalimumab) lowers inflammation to relieve symptoms in different parts of your body.

Are you looking for information on Humira (adalimumab) instead?

Drug facts

Common Brands	Hulio
Drug Class	Biologic DMARD
Controlled Substance Classification	Not a controlled medication
Generic Status	No lower-cost generic available
Availability	Prescription only

Common Brands

Hulio

Drug Class

Biologic DMARD

Controlled Substance Classification

Not a controlled medication

Generic Status

No lower-cost generic available

Availability

Prescription only

Side effects of Hulio (adalimumab)

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

Injection site reaction (20%)
Upper respiratory tract infection (17%)
Headache (12%)
Rash (12%)
Sinus inflammation (11%)
Accidental injury (10%)
Nausea (9%)
Urinary tract infection (UTI) or bladder infection (8%)

Less Common Side Effects

High cholesterol
High blood pressure
Back pain
Stomach pain
Hair loss
Blood in the urine
Flu-like symptoms

Hulio (adalimumab) serious side effects

Contact your healthcare provider immediately if you experience any of the following.

Serious infection: fever, cough, weight loss, muscle aches, dark urine, chills, vomiting
Severe allergic reaction: rash, trouble breathing, swelling of your face, eyes, lips, or mouth, hives
Low blood cell counts: fever that doesn't go away, easy bruising or bleeding, pale skin
Heart failure: shortness of breath, swelling in the legs, ankles, or feet, irregular heartbeat, tiredness, sudden weight gain
Liver problems: feeling tired, vomiting, yellow skin or whites of the eyes, stomach pain

Source: FDA

The following Hulio (adalimumab) side effects have also been reported

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Body aches or pain

cough

ear congestion

gas with stomach pain

hoarseness

lightheadedness

loss of voice

lower back or side pain

muscle aches and pains

pain or tenderness around the eyes or cheekbones

rapid and sometimes shallow breathing

shivering

stomach fullness

stuffy nose

sunken eyes

thirst

trouble sleeping

warmth on the skin

wrinkled skin

Less common

Abnormal vaginal bleeding or discharge

agitation

arm, back, or jaw pain

black, tarry stools

bleeding from the gums or nose

blindness

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the stool or change in bowel habits

bloody or cloudy urine

blurred vision

broken bones

change in size, shape, or color of an existing mole

change in skin color

chest pain, tightness, or heaviness

chills

clear or bloody discharge from the nipple

cold hands and feet

confusion

constipation

cough

coughing or spitting up blood

decreased urination

decreased vision

depression

difficulty with breathing

difficulty, burning, or painful urination

dimpling of the breast skin

dizziness

drowsiness

eye pain

fainting

fast, slow, or irregular heartbeat

fever

forgetfulness

frequent urge to urinate

general feeling of illness

hair loss

headache

hives, itching, skin rash

increased thirst

inverted nipple

irregular breathing

irregular pulse

irritability

light colored stools

loss of appetite

lump in the breast or under your arm

lump or swelling in the stomach

mole that leaks fluid or bleeds

muscle cramps or spasms

nausea

new mole

night sweats

no blood pressure or pulse

noisy breathing

numbness or tingling in your arms, legs, or face

pain, redness, or swelling in the arms or legs without any injury present

pale skin

persistent non-healing sore on your skin

pink growth

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

raised, firm, or bright red patch

redness or swelling of the breast

seeing or hearing things that are not there

seizures

sharp back pain just below your ribs

shiny bump on your skin

slurred speech or problems with swallowing

sneezing

sore on the skin of the breast that does not heal

sore throat

sores, ulcers, or white spots on the lips or mouth

spitting up blood

stiff neck

stomach pain

stopping of the heart

sudden high fever or low grade fever for months

sweating

swelling of the face, fingers, feet, or lower legs

swollen glands

swollen neck veins

tiredness

trouble breathing

trouble thinking

unconsciousness

unexplained bruising or bleeding

unpleasant breath odor

unusual tiredness or weakness

unusual weight gain or loss

visual disturbances

vomiting

vomiting of blood or material that looks like coffee grounds

yellow skin or eyes

Incidence not known

Blistering, peeling, or loosening of the skin

diarrhea

inability to move the arms and legs

joint or muscle pain

pinpoint red spots on the skin

red skin lesions, often with a purple center

red, irritated eyes

red, scaling, or crusted skin

sudden numbness and weakness in the arms and legs

unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bladder pain

bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

pounding in the ears

Less common

Abnormal healing

decrease in height

difficulty with moving

difficulty with walking

dry mouth

heartburn

indigestion

loss of hearing

loss of strength or energy

menstrual changes

muscle or joint stiffness, tightness, or rigidity

muscle pain or weakness

pain in the back, ribs, arms, or legs

shakiness in the legs, arms, hands, and feet

swelling or redness in the joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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Avg retail price

$1228.49(Save 18.59%)

$1000.07

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Pros and cons of Hulio (adalimumab)

Pros

Typically only need to give injections a few times per month
Doesn't contain citrate, so injections might be less painful compared to some other adalimumab products
FDA approved for use in children with JIA, CD, or HS
Available as prefilled syringes and pens for convenience
Can be stored at room temperature for up to 14 days if needed (e.g., travel)

Cons

Raises the risk of serious infection
Injections can be uncomfortable for some people
Commonly causes redness, rash, swelling, or itching at the injection site
Live vaccines aren't recommended while taking the medication
Not known if it's safe in pregnancy or breastfeeding

Pharmacist tips for Hulio (adalimumab)

Before using Hulio (adalimumab) at home, you should receive injection training from your healthcare provider or care team. If you haven't, contact the clinic or call 1-800-796-9526. Don't try to give yourself an Hulio (adalimumab) injection until you've been shown how to do it correctly.
Mark when your doses of Hulio (adalimumab) are due on your calendar to help you remember to take it. The medication will work best if you take it consistently.
Take Hulio (adalimumab) out of the refrigerator and let it warm up to room temperature for about 15 to 30 minutes to help reduce discomfort with the injection. Never put it in the microwave or in hot water because this could damage the medication.
You can inject Hulio (adalimumab) under your skin on your lower stomach (at least 2 inches away from your belly button) or on the front of your thighs. To allow your skin to heal, make sure to rotate your injection sites each time. And don't inject into skin that's red, bruised, or broken.
Keep unused Hulio (adalimumab) in the refrigerator in its original container to protect it from light. But you can leave it at room temperature for 14 days, just make sure to throw it away after that time.
Throw away used needles, syringes, and autoinjectors in a sharps container to prevent needlestick injuries. You can use an FDA-cleared container or heavy-duty plastic container you have at home. Check your local laws and guidelines for how to dispose of your container once it's almost full.
Before getting any vaccines, let your provider or pharmacist know you're taking Hulio (adalimumab). It's recommended to avoid live vaccines while you're taking this medication. And make sure your child gets all of their appropriate shots before starting Hulio (adalimumab).

Common questions about Hulio

Hulio was approved by the FDA in 2020, but it's not yet available on the market. It's expected to be available in the United States in July 2023.

Hulio is a biosimilar to Humira (adalimumab). This means it has a comparable structure and works similarly to Humira, the original medication approved by the FDA. Biosimilars are like generics, but they're not exactly the same as the original biologic. Compared to Hulio, Humira (adalimumab) is additionally FDA approved to treat uveitis (inflammation in the middle layer of the eye) for children and adults, but Hulio is only approved to treat that condition in adults.

In a clinical study, researchers found that Hulio worked just as well as Humira (adalimumab) for treating rheumatoid arthritis. They also found that it had similar side effects.

It's not entirely known. In one clinical trial, people who took adalimumab (the active ingredient in Hulio) in pregnancy didn't have a higher risk of harm to themselves or their unborn babies. While this is reassuring, there currently isn't enough information to know if Hulio is completely safe during pregnancy. If you're pregnant or thinking of becoming pregnant, speak to your provider about the risks and benefits for you and your unborn baby.

If you forget to take your dose of Hulio, inject a dose as soon as you remember. Then, take your next dose at your normal scheduled time. Never double up to make up for your missed dose because this could lead to side effects. If you have questions about when you should take Hulio, contact your healthcare provider or pharmacist.

Risks and warnings for Hulio (adalimumab)

Hulio (adalimumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

Serious infections

Risk factors: Taking other medications that weaken the immune system | Older adults | Active, long-term, or an infection that keeps coming back | Traveling to high risk areas | Having other conditions that raise the risk of infection

Black Box Warning Hulio (adalimumab) blocks TNF, a protein that plays an important role in your immune system. As a result, it can raise your risk of serious and life-threatening infections. Your risk is higher if you're an older adult, taking other medications that can weaken the immune system (e.g., methotrexate, Orencia (abatacept), Kineret (anakinra), corticosteroids), or if you have other health conditions. Before starting Hulio (adalimumab), make sure to discuss your full medical history with your provider. Especially let them know if you've ever had tuberculosis or hepatitis B. They'll review your risk before starting the medication. If you develop a serious infection while taking Hulio (adalimumab), you might have to stop the medication in order to give your immune system a chance to fight the infection.

Cancers

Risk factors: Taking other medications that weaken the immune system | History of cancer | People with chronic obstructive pulmonary disease (COPD) with a history of smoking

Black Box Warning In clinical studies, there was a greater number of people who developed cancer while taking a medication like Hulio (adalimumab) compared to people who didn't take that medication. Some of the most commonly reported types of cancer in people who used that medication were lymphoma, leukemia, and skin cancers. Your provider will determine your risk before starting Hulio (adalimumab) and monitor you while you're taking the medication. Talk to your provider if you have any concerns.

Severe allergic reactions

Products containing adalimumab (the active ingredient in Hulio) have rarely caused allergic reactions. Some reactions can be life threatening, like anaphylaxis (closing of the throat). If you experience rash, trouble breathing, itching, or swelling in your face or throat, get medical help right away.

Nervous system effects

Risk factors: Currently have or recently developed a nervous system condition

Although rare, people taking medications like Hulio (adalimumab) have developed conditions that affect the nervous system, such as multiple sclerosis (MS) and Guillain-Barré syndrome. Let your provider know if you currently have nerve problems. They'll want to monitor you closely while you're taking Hulio (adalimumab), since it can make them worse. Call your provider right away if you notice numbness or tingling, weakness in your arms or legs, vision problems, or dizziness.

Low blood cell counts

Although rare, some people taking medications like Hulio (adalimumab) experienced low amounts of blood cells. This can raise your risk for bleeding and lower your body's ability to fight infections. Contact your provider if you develop a fever that doesn't go away, easy bruising, pale skin, or bleeding.

Heart failure

People taking medications like Hulio (adalimumab) have had new or worsening cases of heart failure. Speak with your provider if you currently have heart failure. They'll weigh the benefits and risks to determine if Hulio (adalimumab) is right for you. If you start to have shortness of breath, swelling in the legs, ankles, or feet, irregular heartbeat, or tiredness or weakness, get medical help right away as these can be signs of heart failure.

Lupus-like syndrome

Rarely, Hulio (adalimumab) can cause a condition called lupus-like syndrome. Contact your provider if you experience a rash, easy bruising or bleeding, or feel unusually tired.

Hulio (adalimumab) dosage

The average cost for 1 carton of 2 pens of 40mg/0.8ml of Hulio (adalimumab) is $3,385.72 with a free GoodRx coupon. This is 57.10% off the average retail price of $7,892.59.

Carton

Dosage	Quantity	Price as low as	Price per unit
2 syringes of 40mg/0.8ml	1 carton	$6,638.16	$6,638.16
2 pens of 40mg/0.8ml	1 carton	$3,385.72	$3,385.72

Typical dosage for Hulio (adalimumab)

Adults

Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: The typical starting dose is 40 mg injected under the skin every other week.
Crohn's disease and ulcerative colitis: The typical dose is 160 mg injected under the skin on Day 1, followed by 80 mg on Day 15, then 40 mg every other week starting Day 29.
Plaque psoriasis and uveitis: The typical dose is 80 mg injected under the skin on Day 1, followed by 40 mg every other week starting 1 week after the first dose.
Hidradenitis suppurativa: The typical dose is 160 mg injected under the skin on Day 1, followed by 80 mg on Day 15, then 40 mg every week OR 80 mg every other week starting Day 29.

Children

Juvenile idiopathic arthritis and Crohn's disease: The dose will be based on your child's body weight. Typically it will be injected under the skin once every other week.

Interactions between Hulio (adalimumab) and other drugs

Hulio (adalimumab) may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking. The list below does not include all possible drug interactions with Hulio (adalimumab). Please note that only the generic name of each medication is listed below.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.