When will Hadlima (adalimumab) be available?

Although Hadlima (adalimumab) was already approved by the FDA in 2019, it's expected to be available in the United States on or after [July 2023](https://www.organon.com/news/samsung-bioepis-and-organon-announce-fda-approval-of-citrate-free-high-concentration-humira-biosimilar-hadlima-adalimumab-bwwd/).

Hadlima

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

Basics Side effects Pros & cons Pharmacist tips FAQs Warnings Dosage Interactions Cost Alternatives Latest news Prices Medicare

Hadlima (adalimumab or adalimumab-bwwd) is used to treat many different autoimmune conditions, including some types of arthritis, Crohn's disease (CD), ulcerative colitis (UC), and plaque psoriasis. It's injected under the skin and comes as both prefilled syringes and an autoinjector. This medication is a biosimilar to Humira (adalimumab). And it's expected to be available in the United States on or after July 2023.

Reviewed by:

Kristianne Hannemann, PharmD

Daisy Chau, PharmD

Last reviewed on December 20, 2022

Basics Side effects Pros & cons Pharmacist tips FAQs Warnings Dosage Interactions Cost Alternatives Latest news Prices Medicare

What is Hadlima (adalimumab)?

What is Hadlima (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 Hadlima (adalimumab) works

Hadlima (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, Hadlima (adalimumab) lowers inflammation to relieve symptoms in different parts of your body.

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

Drug facts

Common BrandsHadlima

Drug ClassBiologic DMARD

Controlled Substance ClassificationNot a controlled medication

Generic StatusNo lower-cost generic available

AvailabilityPrescription only

Side effects of Hadlima (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

Hadlima (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
Low blood cell counts: fever that doesn't go away, easy bruising or bleeding, pale skin
Severe allergic reaction: rash, hives, trouble breathing, swelling of your face, eyes, lips, or mouth
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: Prescribing Information

The following Hadlima (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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Pros and cons of Hadlima (adalimumab)

Pros

Works treat many different autoimmune conditions
Typically only injected a few times per month
Conveniently available as a prefilled syringe or autoinjector
Higher strength might be less painful to inject

Cons

Raises the risk for serious infections
Might raise the risk of lymphoma and skin cancers
Must avoid live vaccines while taking the medication
Not known if it's safe in pregnancy or breastfeeding

Pharmacist tips for Hadlima (adalimumab)

It can be helpful to mark the days on your calendar when your doses of Hadlima (adalimumab) are due.
Before using Hadlima (adalimumab) at home, you should receive injection training from your healthcare provider or care team. If you haven't, contact the clinic or call 1-844-674-3200. Don't try to give yourself a Hadlima (adalimumab) injection until you've been shown the right way to do it.
Store unused Hadlima (adalimumab) in the refrigerator up to the expiration date. But you can also store it at room temperature for up to 14 days. Just remember to throw it away if you don't use it all within that time.
When ready for your dose, take Hadlima (adalimumab) out of the refrigerator and let it warm up to room temperature for about 15 to 30 minutes. This will help lower discomfort with the injection. Never warm it up by putting it in the microwave or hot water because this could damage the medication.
Don't use Hadlima (adalimumab) if you accidentally drop it and you think it might be broken, since it's made of glass. And if the cap was off of the syringe, the needle could be dirty or damaged.
Throw away your used needles and syringes in a sharps container or other container made of heavy duty plastic to prevent needlestick injuries. When it's full, follow your local laws on how to discard it correctly.
Avoid getting live vaccines while you're taking Hadlima (adalimumab). And make sure your child gets all of their appropriate shots before starting the medication. Talk to your provider or pharmacist before getting any vaccines to be on the safe side.

Common questions about Hadlima (adalimumab)

Although Hadlima (adalimumab) was already approved by the FDA in 2019, it's expected to be available in the United States on or after July 2023.

Hadlima (adalimumab) is a biosimilar to Humira (adalimumab). This means it's kind of like a generic to Hadlima (adalimumab), but not exactly. Hadlima (adalimumab) has a similar structure and works to treat conditions in the same way as Humira (adalimumab) does. But Hadlima (adalimumab) isn't FDA approved to treat all age groups within a condition that Humira (adalimumab) is. For example, Humira (adalimumab) is FDA approved to treat uveitis (inflammation in the middle layer of the eye) in children and adults, while Hadlima (adalimumab) is approved for use in adults only.

While Hadlima (adalimumab) works similarly to other Humira biosimilars, there are a few differences between them. Hadlima (adalimumab) has been FDA approved for two different strengths (50 mg/mL and 100 mg/mL), whereas other Humira biosimilars are currently only available in the 50 mg/mL strength. And unlike some of the other biosimilars, it also comes as an autoinjector, which might be easier to use than the prefilled syringes. In addition, injections with the higher strength of Hadlima (adalimumab) might be less painful because it's made without citrate, an ingredient that can cause more pain with the injection.

Hadlima (adalimumab) should be injected in the fatty area under your skin. You can inject it either 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 avoid injecting the medication into skin that's red, bruised, or broken.

Hadlima (adalimumab) works best if you take it consistently. But if you accidentally forget your dose, inject a dose as soon as possible. Then, inject your next dose at your regularly scheduled time. If you have questions about when you should inject Hadlima (adalimumab), ask your provider or pharmacist.

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Risks and warnings for Hadlima (adalimumab)

Hadlima (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 | Age 65 years or older | 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 Hadlima (adalimumab) can raise your risk of serious or life-threatening infections. Your risk might be higher if you're 65 years or older, taking other medications that can weaken the immune system (e.g., methotrexate, Orencia (abatacept), Kineret (anakinra), corticosteroids), and or have other health conditions. Make sure to discuss your medical history with your provider before starting Hadlima (adalimumab), especially if you've ever had tuberculosis or hepatitis B. They'll review your risk before starting the medication. If you get an infection while taking Hadlima (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 trials, there was a greater number of people who developed cancer while taking a medication similar to Hadlima (adalimumab) when compared to people not taking that medication. Cancers like lymphoma, leukemia, and skin cancers were the most commonly reported types in that study. Your provider will evaluate your risk before starting Hadlima (adalimumab) and monitor you while you're taking the medication. Speak to your provider if you have any concerns.

Severe allergic reactions

Rarely, Hadlima (adalimumab) can cause severe allergic reactions. Some reactions may be life-threatening, like anaphylaxis (closing of the throat). If you experience rash, itching, trouble breathing, or swelling in your face, lips, tongue, or throat, get medical help right away.

Nervous system effects

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

Hadlima (adalimumab) can rarely cause you to develop nervous system problems, such as multiple sclerosis (MS) and Guillain-Barré syndrome. Let your provider know if you currently have a nervous system condition. They'll want to monitor you closely while you're taking Hadlima (adalimumab), since it can make these problems worse. If you experience numbness or tingling, weakness in your arms or legs, vision problems, or dizziness, call your provider.

Low blood cell counts

Some people taking Hadlima (adalimumab) have experienced low blood cells. This can lower your body's ability to fight infections and raise your risk for bleeding. 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 Hadlima (adalimumab) have had new or worsening cases of heart failure. Tell your provider if you currently have heart failure. They'll help you decide if Hadlima (adalimumab) is right for you. Get medical help right away if you start to have shortness of breath, swelling in the legs, ankles, or feet, irregular heartbeat, or tiredness or weakness, as these can be signs of heart failure.

Lupus-like syndrome

Hadlima (adalimumab) can rarely cause a condition called lupus-like syndrome. If you experience easy bruising or bleeding, a rash, or feel unusually tired, call your provider to let them know.

Hadlima (adalimumab) dosage

The average cost for 1 carton of 2 autoinjectors of 40mg/0.4ml of Hadlima (adalimumab) is $1,002.73 with a free GoodRx coupon. This is 34.13% off the average retail price of $1,522.32.

Carton

Dosage	Quantity	Price as low as	Price per unit
2 autoinjectors of 40mg/0.8ml	1 carton	$1,002.73	$1,002.73
2 syringes of 40mg/0.8ml	1 carton	$1,002.73	$1,002.73
2 autoinjectors of 40mg/0.4ml	1 carton	$1,002.73	$1,002.73
2 syringes of 40mg/0.4ml	1 carton	$1,002.73	$1,002.73

Typical dosage for Hadlima (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 Hadlima (adalimumab) and other drugs

Hadlima (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 Hadlima (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.