Say Hello to Adalimumab-fkjp - Information | Adalimumab-fkjpInjection Pen

Built with you in mind

The easy-to-use, 2-click Adalimumab-fkjp prefilled pen makes starting treatment as simple as “click, click, go!”¹ Just push the device against the skin to trigger the injection and watch the indicator display your progress. There is no button to press.²

Adalimumab-fkjp is also available in 20 mg/0.4 mL and 40 mg/0.8 mL prefilled syringes.

Adalimumab-fkjp is an interchangable biosimilar to Humira (adalimumab)

A biosimilar is a biologic drug that’s very similar to the original approved medicine. Since it’s nearly an exact copy of the original, there are no clinically meaningful differences between the two drugs.^2,3

Adalimumab-fkjp helps treat the inflammation
associated with your condition

Adalimumab-fkjp works by blocking a certain protein in the body called TNF-α. Having too much
TNF-α causes inflammation that can increase disease symptoms, anywhere from joints to GI
tract to skin. By blocking TNF-α, adalimumab is proven effective at reducing the inflammation.²

Rheumatology

Moderate to Severe

Rheumatoid Arthritis

in adults

ACTIVE

Psoriatic Arthritis

in adults

active

Ankylosing Spondylitis

in adults

Moderate to Severe Polyarticular

Juvenile Idiopathic Arthritis

in children 2 years of age and older

Dermatology

Moderate to Severe Chronic

Plaque Psoriasis

in adults

Moderate to Severe

Hidradenitis Suppurativa

in adults

Gastroenterology

Moderate to Severe

Crohn’s Disease

in adults and children 6 years of age and older

Moderate to Severe

Ulcerative Colitis

in adults

Ophthalmology

NON-INFECTIOUS

Uveitis

in adults

Rheumatology

Moderate to Severe

Rheumatoid Arthritis

in adults

ACTIVE

Psoriatic Arthritis

in adults

active

Ankylosing Spondylitis

in adults

Moderate to Severe Polyarticular

Juvenile Idiopathic Arthritis

in children 2 years of age and older

Dermatology

Moderate to Severe Chronic

Plaque Psoriasis

in adults

Moderate to Severe

Hidradenitis Suppurativa

in adults

Gastroenterology

Moderate to Severe

Crohn’s Disease

in adults and children 6 years of age and older

Moderate to Severe

Ulcerative Colitis

in adults

Ophthalmology

NON-INFECTIOUS

Uveitis

in adults

Moderate to Severe

Rheumatoid Arthritis

in adults

Moderate to Severe Chronic

Plaque Psoriasis

in adults

Moderate to Severe

Crohn’s Disease

in adults and children 6 years of age and older

NON-INFECTIOUS

Uveitis

in adults

ACTIVE

Psoriatic Arthritis

in adults

Moderate to Severe

Hidradenitis Suppurativa

in adults

Moderate to Severe

Ulcerative Colitis

in adults

active

Ankylosing Spondylitis

in adults

Moderate to Severe Polyarticular

Juvenile Idiopathic Arthritis

in children 2 years of age and older

Biosimilars aren’t just what we do—they’re all we do

Each year, biosimilars save the US healthcare system over $5 billion.*⁴ By increasing the availability of high-quality biosimilars such as Adalimumab-fkjp here and around the world, Biocon Biologics aims to help make a meaningful difference for you.

5.5 MILLION PATIENTS

treated in over 100 countries

9 BIOSIMILARS

available worldwide

20+ BIOSIMILARS

approved or in development

Learn more about Biocon Biologics here.

*Estimated decrease in direct spending on biologic drugs from 2014 through 2024.

Reference: 1. Serrecchia T, Waller KA, Ishikawa T, Muniz R, Varricchione TR. Human factors validation for a rheumatoid arthritis auto-injector for the adalimumab biosimilar FKB327.  Int J Hum Factors Ergon. 2020;7(2):144-160. 2. Adalimumab fkjp. Product information. Biocon Biologics Inc; 2025.

Important Safety Information

What is the most important information I should know about Adalimumab-fkjp?

You should discuss the potential benefits and risks of Adalimumab-fkjp with your doctor. Adalimumab-fkjp is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking Adalimumab-fkjp if you have any kind of infection unless your doctor says it is okay.

Serious 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 Adalimumab-fkjp and check you closely for signs and symptoms of TB during treatment with Adalimumab-fkjp, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.

Cancer

For children and adults taking TNF blockers, including Adalimumab-fkjp, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including Adalimumab-fkjp, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting Adalimumab-fkjp?

Tell your doctor about all of your health conditions, including if you:

Have an infection, are being treated for infection, or have symptoms of an infection
Get a lot of infections or infections that keep coming back
Have diabetes
Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use Adalimumab-fkjp. Ask your doctor if you are unsure if you have lived in an area where these infections are common.
Have or have had hepatitis B
Are scheduled for major surgery
Have or have had cancer
Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
Have or had heart failure
Have recently received or are scheduled to receive a vaccine. Adalimumab-fkjp patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting Adalimumab-fkjp
Are allergic to Adalimumab-fkjp or to any of its ingredients
Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
Have a baby and you were using Adalimumab-fkjp during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines

Also tell your doctor about all the medicines you take. You should not take Adalimumab-fkjp with ORENCIA^® (abatacept), KINERET^® (anakinra), REMICADE ^® (infliximab), ENBREL^® (etanercept), CIMZIA^® (certolizumab pegol), or SIMPONI^® (golimumab). Tell your doctor if you have ever used RITUXAN^® (rituximab), IMURAN^® (azathioprine), or PURINETHOL ^® (6-mercaptopurine, 6-MP).

What should I watch for AFTER starting Adalimumab-fkjp?

Adalimumab-fkjp can cause serious side effects, including:

Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.
Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.

The most common side effects of Adalimumab-fkjp include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, and rash. These are not all of the possible side effects with Adalimumab-fkjp. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:

Fever, sweats, or chills
Muscle aches
Cough
Shortness of breath
Blood in phlegm
Weight loss
Warm, red, or painful skin or sores on your body
Diarrhea or stomach pain
Burning when you urinate
Urinating more often than normal
Feeling very tired

If you have any questions about this information, be sure to discuss them with your healthcare provider.

APPROVED USES

Adalimumab-fkjp is a prescription medicine used:

To reduce the signs and symptoms of:
- Moderate to severe rheumatoid arthritis (RA) in adults. Adalimumab-fkjp can be used alone, with methotrexate, or with certain other medicines. Adalimumab-fkjp may prevent further damage to your bones and joints and may help your ability to perform daily activities.
- Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. Adalimumab-fkjp can be used alone or with methotrexate.
- Psoriatic arthritis (PsA) in adults. Adalimumab-fkjp can be used alone or with certain other medicines. Adalimumab-fkjp may prevent further damage to your bones and joints and may help your ability to perform daily activities.
- Ankylosing spondylitis (AS) in adults.
- Moderate to severe hidradenitis suppurativa (HS) in adults.
To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about Adalimumab-fkjp?

Serious 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 Adalimumab-fkjp and check you closely for signs and symptoms of TB during treatment with Adalimumab-fkjp, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.

Cancer

For children and adults taking TNF blockers, including Adalimumab-fkjp, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including Adalimumab-fkjp, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting Adalimumab-fkjp?

Tell your doctor about all of your health conditions, including if you:

Have an infection, are being treated for infection, or have symptoms of an infection
Get a lot of infections or infections that keep coming back
Have diabetes
Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use Adalimumab-fkjp. Ask your doctor if you are unsure if you have lived in an area where these infections are common.
Have or have had hepatitis B
Are scheduled for major surgery
Have or have had cancer
Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
Have or had heart failure
Have recently received or are scheduled to receive a vaccine. Adalimumab-fkjp patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting Adalimumab-fkjp
Are allergic to Adalimumab-fkjp or to any of its ingredients
Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
Have a baby and you were using Adalimumab-fkjp during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines

What should I watch for AFTER starting Adalimumab-fkjp?

Adalimumab-fkjp can cause serious side effects, including:

Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.
Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.

Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:

Fever, sweats, or chills
Muscle aches
Cough
Shortness of breath
Blood in phlegm
Weight loss
Warm, red, or painful skin or sores on your body
Diarrhea or stomach pain
Burning when you urinate
Urinating more often than normal
Feeling very tired

If you have any questions about this information, be sure to discuss them with your healthcare provider.

APPROVED USES

Adalimumab-fkjp is a prescription medicine used:

To reduce the signs and symptoms of:
- Moderate to severe rheumatoid arthritis (RA) in adults. Adalimumab-fkjp can be used alone, with methotrexate, or with certain other medicines. Adalimumab-fkjp may prevent further damage to your bones and joints and may help your ability to perform daily activities.
- Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. Adalimumab-fkjp can be used alone or with methotrexate.
- Psoriatic arthritis (PsA) in adults. Adalimumab-fkjp can be used alone or with certain other medicines. Adalimumab-fkjp may prevent further damage to your bones and joints and may help your ability to perform daily activities.
- Ankylosing spondylitis (AS) in adults.
- Moderate to severe hidradenitis suppurativa (HS) in adults.
To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker medicines.
To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults.

Click, Click,

Meet Adalimumab-fkjp

Built with you in mind

Protective Cap

Citrate Free

Viewing Window

2 Audible Clicks

Plastic Design

Made Without Natural Rubber Latex

Adalimumab-fkjp is an interchangable biosimilar to Humira (adalimumab)

Adalimumab-fkjp works like Humira

Adalimumab-fkjp provides relief like Humira

Adalimumab-fkjp is as safe as Humira

Adalimumab-fkjp helps treat the inflammation associated with your condition

Moderate to Severe

Rheumatoid Arthritis

ACTIVE

Psoriatic Arthritis

active

Ankylosing Spondylitis

Moderate to Severe Polyarticular

Juvenile Idiopathic Arthritis

Moderate to Severe Chronic

Plaque Psoriasis

Moderate to Severe

Hidradenitis Suppurativa

Moderate to Severe

Crohn’s Disease

Moderate to Severe

Ulcerative Colitis

NON-INFECTIOUS

Uveitis

Moderate to Severe

Rheumatoid Arthritis

ACTIVE

Psoriatic Arthritis

active

Ankylosing Spondylitis

Moderate to Severe Polyarticular

Juvenile Idiopathic Arthritis

Moderate to Severe Chronic

Plaque Psoriasis

Moderate to Severe

Hidradenitis Suppurativa

Moderate to Severe

Crohn’s Disease

Moderate to Severe

Ulcerative Colitis

NON-INFECTIOUS

Uveitis

Rheumatology

Dermatology

Gastroenterology

Ophthalmology

Moderate to Severe

Rheumatoid Arthritis

Moderate to Severe Chronic

Plaque Psoriasis

Moderate to Severe

Crohn’s Disease

NON-INFECTIOUS

Uveitis

ACTIVE

Psoriatic Arthritis

Moderate to Severe

Hidradenitis Suppurativa

Moderate to Severe

Ulcerative Colitis

active

Ankylosing Spondylitis

Moderate to Severe Polyarticular

Juvenile Idiopathic Arthritis

Biosimilars aren’t just what we do—they’re all we do

5.5 MILLION PATIENTS

9 BIOSIMILARS

20+ BIOSIMILARS

Learn more about Biocon Biologics here.

Important Safety Information

APPROVED USES

IMPORTANT SAFETY INFORMATION

Adalimumab-fkjp works
like Humira

Adalimumab-fkjp provides
relief like Humira

Adalimumab-fkjp is as safe
as Humira

Adalimumab-fkjp helps treat the inflammation
associated with your condition