Biosimilars are highly similar to FDA-approved biologic medications
Paying for medications that are needed on a regular basis can add up quickly. For those with chronic conditions that require lifelong management on prescription drugs-such as some autoimmune or autoinflammatory diseases-a commitment to good health may come with a high price tag. (2,3)
Medication alternatives
Patients may not realize that for many brand-name biologics-such as HUMIRA® (adalimumab), a drug commonly used to treat certain autoimmune or autoinflammatory diseases-biosimilar alternatives exist. A biosimilar is a biologic medicine that has been developed to be highly similar to an already FDA-approved biologic, also called a reference product. (1)
“What generics were to the US health care system in the 20th century is what biosimilars have the potential to become in the 21st century: a paradigm shift that may deliver more competition, increase treatment options and help lower costs to the health care system,” said Jon Martin, US commercial lead of biosimilars at Organon. (4,5,6,7)
A biosimilar has no clinically meaningful differences from the reference product. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product. (1)
Affordability
The potential financial savings to patients and to the health care system may be considerable when a lower-cost biosimilar is used instead of a higher-cost branded biologic. (5)
According to IQVIA research, HUMIRA is a more expensive option than its biosimilars for health plans, even after rebates, with a net price of about $2,100 compared to less than $1,000 for some biosimilars, as of April 2024. (8) This underscores why access to potentially more affordable options such as biosimilars is so critical. (1)
“In a hypothetical world, research shows if all HUMIRA patients were switched to any of the HUMIRA biosimilars, employers and patients combined could save up to $6 billion,” said Martin. (8) “It would reduce both the direct cost of coverage, copays and associated administrative fees, which can be high.” (8)
Inevitably, the follow-up question to that is …
Is a biosimilar right for you?
Patients rightfully seek a trusted health care provider, but that doesn’t mean they can’t also ask questions and advocate for themselves and their care. When prescribing a biologic treatment, physicians have the opportunity to share what options might be available to best suit their patient’s lifestyle, including affordability. Biosimilars are as safe and effective as the original biologic/reference product, but at a potentially more affordable price. (1)
For patients taking HUMIRA, HADLIMA™ (adalimumab-bwwd) is one biosimilar option that may be available at a fraction of the cost. (9) On average, patients paid more than four times as much out of pocket per month for HUMIRA (adalimumab) compared to HADLIMA (cost and coverage for HADLIMA is dependent on the terms and conditions of one’s individual insurance benefit, including any applicable deductible, co-insurance, or co-payment).* (10)
HADLIMA is a tumor necrosis factor (TNF) blocker indicated for appropriate patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. See full indications below. Patients treated with adalimumab products, including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death. Discontinue HADLIMA if a patient develops a serious infection or sepsis. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of tuberculosis (TB) in patients who tested negative for latent TB infection prior to initiating therapy. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. See additional safety information below.
The best thing patients can do is educate themselves on their care. Ask questions. Do research. Discuss the availability of a biosimilar, the potential cost savings that could come with switching, and how it might impact out-of-pocket costs. (1)
WHAT IS HADLIMA?
HADLIMA is a prescription medicine used:
- To reduce the signs and symptoms of:
- Moderate to severe rheumatoid arthritis (RA) in adults. HADLIMA can be used alone, with methotrexate, or with certain other medicines.
- Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HADLIMA can be used alone or with methotrexate.
- Psoriatic arthritis (PsA) in adults. HADLIMA can be used alone or with certain other medicines.
- 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 (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
- 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 HADLIMA?
You should discuss the potential benefits and risks of HADLIMA with your doctor. HADLIMA is a tumor necrosis factor (TNF) blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HADLIMA if you have any kind of infection unless your doctor says it is okay.
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 HADLIMA, and check you closely for signs and symptoms of TB during treatment with HADLIMA, 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 HADLIMA, 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 HADLIMA, your chance of getting 2 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 does not heal.
What should I tell my doctor BEFORE starting HADLIMA?
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 HADLIMA. Ask your doctor if you are unsure if you have lived in these areas.
- 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. HADLIMA patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting HADLIMA.
- Are allergic to HADLIMA or any of its ingredients.
- Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.
- Have a baby and were using HADLIMA 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 HADLIMA 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® (mercaptopurine, 6-MP).
What should I watch for after starting HADLIMA?
HADLIMA 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.
Common side effects of HADLIMA include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HADLIMA. 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
HADLIMA is given by injection under the skin.
This is the most important information to know about HADLIMA. For more information, talk to your health care provider.
Please read the accompanying Medication Guide for HADLIMA, including the information about serious infections and cancers, and discuss it with your doctor. The Instructions for Use and Physician Prescribing Information also are available.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
To learn more about HADLIMA, click or tap here.
HUMIRA is a trademark registered in the US by AbbVie Biotechnology Ltd; Organon is not associated with this trademark owner.
*Based on analysis of actual patient claims processed from July 2023 to August 2024, with the average out-of-pocket costs being $215 vs $48 for HUMIRA and HADLIMA, respectively.
1. Biosimilars basics for patients. US Food and Drug Administration; 2024. Accessed March 5, 2025. https://www.fda.gov/drugs/biosimilars/biosimilars-basics-patients
2. The US generic & biosimilar medicines savings report. Association for Accessible Medicines (AAM). September 2022. Accessed March 5, 2025. https://accessiblemeds.org/wp-content/uploads/2024/12/AAM-2022-Generic-Biosimilar-Medicines-Savings-Report.pdf
3. Data available on request from Organon Professional Services-DAP (Marketing Operations), 30 Hudson St., Jersey City, NJ 07302. Please specify information package US-ADA-110317.
4. Gottlieb S. Dynamic regulation: key to maintaining balance between biosimilars innovation and competition. US Food and Drug Administration. July 18, 2018. Accessed August 7, 2025. https://www.fda.gov/news-events/speeches-fda-officials/dynamic-regulation-key-maintaining-balance-between-biosimilars-innovation-and-competition-07182018
5. Aitken M, Kleinrock M, Pritchett J. Biosimilars in the United States 2023-2027: competition, savings, and sustainability. IQVIA Institute for Human Data Science. January 31, 2023. Accessed March 5, 2025. https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2023-2027
6. Biosimilars action plan. US Food and Drug Administration; 2024. Accessed March 5, 2025. https://www.fda.gov/drugs/biosimilars/biosimilars-action-plan#efficiency
7. Biosimilar and interchangeable biologics: more treatment choices. US Food and Drug Administration. Updated August 17, 2023. Accessed March 5, 2025. https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices
8. Adalimumab biosimilars tracking: Q1 2024 readout. Biosimilars Council; 2024. Accessed March 5, 2025. https://biosimilarscouncil.org/wp-content/uploads/2024/04/04022024_IQVIA-Humira-Tracking-Executive-Summary.pdf
9. Medi-Span® Price Rx® Pro Data – Adalimumab Products. Updated October 6, 2023. Accessed March 5, 2025.
10. Data available on request from Organon Professional Services-DAP (Marketing Operations), 30 Hudson St., Jersey City, NJ 07302. Please specify information package REF-146241.
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