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HomeAboutAboutBiologics & BiosimilarsAbout ABRILADADosingTotality of EvidenceTotality of EvidenceStructural & Functional SimilarityEfficacySafety & ImmunogenicityExtrapolationMultiple-Switching StudyProduct InformationReimbursement & SupportReimbursement
& SupportPfizer enCompass & All in 1 AppMaterialsVideos
Full Prescribing Information, including BOXED WARNINGMedication GuideInstructions for UseIndications Patient Site Información de Prescripción Completa
Help your patients on their treatment journey without missing a stepWhether they are new to, or currently treated with, adalimumabABRILADA™ (adalimumab-afzb)
Injection: 40 mg/0.8 mL, 20 mg/0.4 mLPfizer’s FDA-approved, citrate-free, interchangeable biosimilar to Humira® (adalimumab), available in pens and prefilled syringes1,2*†ABRILADA is Pfizer’s 9th FDA‑approved biosimilar3,4*
  • No clinically meaningful differences from Humira1
  • Evidence established in the first and only multiple switching study in patients with moderately to severely active RA supporting an FDA interchangeability designation2,5
See totality of evidenceLoading
  • Citrate-free formulation1
  • Devices made without natural rubber latex, which may reduce the likelihood of an allergic reaction1,6
  • 30-day out-of-refrigerator stability¹
  • Available in pens and prefilled syringes1
Explore product information
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  • Access and patient support
  • Educational materials
See patient support
LoadingABRILADA is interchangeable with Humira2*†FDA interchangeable designation supported by a separate phase 3, multiple-switching study2,5‡
  • The first and only interchangeable adalimumab biosimilar with a multiple-switching study in patients with moderately to severely active RA2,5
  • Patients switching back and forth from ABRILADA and Humira multiple times saw no clinically meaningful differences in safety, immunogenicity, or pharmacokinetics5
  • ABRILADA is interchangeable with Humira for all eligible indications1,2
See multiple-switching study
LoadingStudy description: Phase 3, open-label, randomized, parallel-group multiple-switching study of ABRILADA and Humira in patients with moderately to severely active RA who had received methotrexate for 12 or more weeks, and had been on a stable dose for ≥4 weeks before first dose of study medication. All patients received Humira for the first 10 weeks of the study. At week 10, patients were randomized to either a switching group (3 switches between Humira and ABRILADA), or a non-switching group (continuous dosing with Humira). Primary endpoints were maximum observed serum concentration (Cmax) and area under plasma concentration–time curve (AUCτ) during weeks 30–32 in the PK population.5ABRILADA is interchangeable for the indications of use, dosage forms, strengths and routes of administration described in Prescribing Information.1,2ABRILADA is approved for all indications of Humira except pediatric ulcerative colitis, adolescent hidradenitis suppurativa, and pediatric uveitis.An interchangeable biosimilar may be substituted at the pharmacy for the reference product without the intervention of the prescribing healthcare provider, depending on state pharmacy laws. Not all biosimilars are interchangeable. An interchangeable designation is granted by the FDA to only those biosimilars that meet additional data requirements demonstrating that patients who alternate between the reference product and the biosimilar will have the same clinical result as patients who are being treated with the reference product alone.7,8

Enrollment required. Limits, terms, and conditions apply.§

Pfizer enCompass® provides access and reimbursement resources, patient support, and educational materials for ABRILADAEligible, commercially insured patients may pay as little as $0 for each ABRILADA treatment§

To enroll your patients in the Pfizer enCompass Co-Pay Assistance Program, contact Pfizer enCompass:
1-844-722-6672, Monday to Friday, 8 AM to 8 PM ET, or visit  www.PFIZERenCompass.com.

Learn more about the program
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§Terms and Conditions: By using this program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions below:
The Pfizer enCompass® Co-Pay Assistance Program for ABRILADA is not valid for patients that are enrolled in a state- or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”). Program offer is not valid for cash-paying patients. Patients prescribed ABRILADA for adolescent hidradenitis suppurativa (HS), pediatric uveitis, or pediatric ulcerative colitis are not eligible for this co-pay savings program. With this program, eligible patients may pay as little as $0 co-pay per ABRILADA treatment, subject to a maximum benefit of $4,000-$14,000 per calendar year for out-of-pocket expenses for ABRILADA, depending on your insurance, including co-pays or coinsurances. The amount of any benefit is the difference between your co-pay and $0. After the maximum benefit, you will be responsible for the remaining monthly out-of-pocket costs. Patient must have private insurance with coverage of ABRILADA. This offer is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other private health or pharmacy benefit programs. You must deduct the value of this assistance from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf. You are responsible for reporting use of the program to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the program, as may be required. You should not use the program if your insurer or health plan prohibits use of manufacturer co-pay assistance programs. This program is not valid where prohibited by law. The benefit under the program is offered to, and intended for the sole benefit of, eligible patients and may not be transferred to or utilized for the benefit of third parties, including, without limitation, third-party payers, pharmacy benefit managers, or the agents of either. This program cannot be combined with any other external savings, free trial, or similar offer for the specified prescription (including any program offered by a third-party payer or pharmacy benefit manager, or an agent of either, that adjusts patient cost-sharing obligations, through arrangements that may be referred to as “accumulator” or “maximizer” programs). Third-party payers, pharmacy benefit managers, or the agents of either, are prohibited from assisting patients with enrolling in the program. Co-pay card will be accepted only at participating pharmacies. If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer. The rebate form can be found at https://patient.pfizeriandicopay.com. This program is not health insurance. This program is good only in the U.S. and Puerto Rico. This program is limited to 1 per person during this offering period and is not transferable. This offer cannot be redeemed more than once per 30 days per patient. No other purchase is necessary. Data related to your redemption of the program assistance may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other assistance redemptions and will not identify you. Pfizer reserves the right to rescind, revoke, or amend this program without notice. This program may not be available to patients in all states. For more information about Pfizer, visit www.pfizer.com. For more information about the Pfizer enCompass Co-Pay Assistance Program, call Pfizer enCompass at 1-844-722-6672, or write to Pfizer enCompass Co-Pay Assistance Program at 2730 S. Edmonds Lane, Suite 300, Lewisville, TX 75067. Card and Program expire 12/31/2024.

The brand names included throughout are the properties of their respective owners.

FDA=Food and Drug Administration; PK=pharmacokinetics; RA=rheumatoid arthritis.References:ABRILADA [prescribing information]. New York, NY: Pfizer, Inc; 2024.US Food and Drug Administration. Purple Book database of licensed biological products. https://purplebooksearch.fda.gov/results?query=adalimumab&title=Abrilada. Accessed November 3, 2023.How many biosimilars have been approved in the United States? Drugs.com. Updated May 23, 2023. https://www.drugs.com/medical-answers/many-biosimilars-approved-united-states-3463281/. Accessed November 3, 2023.Pfizer, Inc https://biosimilars.pfizerpro.com. Pfizer Biosimilars. Accessed November 3, 2023.Fleischmann R, Saikali W, Lakhanpal S, et al. Multiple switching between the biosimilar adalimumab PF-06410293 and reference adalimumab in patients with active rheumatoid arthritis: a phase 3, open-label, randomised, parallel-group study. Lancet Rheumatol. 2023;5:e532-541.Primeau MN, Adkinson NF Jr, Hamilton RG. Natural rubber pharmaceutical vial closures release latex allergens that produce skin reactions. J Allergy Clin Immunol. 2001;107:958-962.US Food and Drug Administration. Interchangeable biological products. https://www.fda.gov/media/151094/download. Accessed November 3, 2023.US Food and Drug Administration. Biosimilar and interchangeable biologics: more treatment choices. https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices. Accessed November 3, 2023.

To report an adverse event, please call 1-800-438-1985

Pfizer for Professionals 1-800-505-4426

This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

© 2024 Pfizer Inc. All rights reserved.

PP-ABD-USA-0232
Indications
  • Rheumatoid Arthritis: ABRILADA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic 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.
  • Juvenile Idiopathic Arthritis: ABRILADA 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.
  • Psoriatic Arthritis: ABRILADA is indicated, 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 psoriatic arthritis.
  • Ankylosing Spondylitis: ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
  • Crohn’s Disease: ABRILADA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
  • Ulcerative Colitis: ABRILADA 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.
  • Plaque Psoriasis: ABRILADA 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. ABRILADA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
  • Hidradenitis Suppurativa: ABRILADA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.
  • Uveitis: ABRILADA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
Please see Full Prescribing Information, including BOXED WARNING, Medication Guide, and Instructions for Use, for ABRILADA.
Important Safety Information and UseSERIOUS INFECTIONS
​​​​​
Patients treated with adalimumab products including ABRILADA 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 ABRILADA 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 disseminated or extrapulmonary disease. Test patients for latent TB before ABRILADA use and during therapy. Initiate treatment for latent TB prior to ABRILADA 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 ABRILADA 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 ABRILADA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
  • Do not start ABRILADA during an active infection, including localized infections.
  • Patients older than 65 years, 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 rheumatoid arthritis (RA) patients treated with rituximab who received subsequent treatment with a tumor necrosis factor (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 ABRILADA with other biologic disease-modifying antirheumatic drugs (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. Post-marketing 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 ABRILADA treatment prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials, more cases of malignancies were observed among adalimumab-treated patients compared to control patients.
  • 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 psoralen plus ultraviolet A (PUVA) therapy, for the presence of NMSC prior to and during treatment with ABRILADA.
  • In 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 higher risk of lymphoma than the general population, even in the absence of TNF blockers.
  • Postmarketing cases of acute and chronic leukemia were reported 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 included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents.

HYPERSENSITIVITY

  • Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If a serious allergic reaction occurs, stop ABRILADA and institute appropriate therapy.
HEPATITIS B VIRUS REACTIVATION
  • Use of TNF blockers, including ABRILADA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases 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 who are carriers of HBV and monitor them during and after ABRILADA treatment.
  • Discontinue ABRILADA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming ABRILADA after HBV treatment.
NEUROLOGIC REACTIONS
  • TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
  • Exercise caution when considering ABRILADA for patients with these disorders; discontinuation of ABRILADA should be considered if any of these disorders develop.
  • There is a known association between intermediate uveitis and central demyelinating disorders.
HEMATOLOGIC REACTIONS
  • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products.
  • Consider stopping ABRILADA if significant hematologic abnormalities occur.
CONGESTIVE HEART FAILURE
  • Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully.
AUTOIMMUNITY
  • Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
IMMUNIZATIONS
  • Patients on ABRILADA should not receive live vaccines.
  • Pediatric patients, if possible, should be brought up to date with all immunizations before initiating ABRILADA 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 ABRILADA 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 in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.
Indications
  • Rheumatoid Arthritis: ABRILADA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic 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.
  • Juvenile Idiopathic Arthritis: ABRILADA 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.
  • Psoriatic Arthritis: ABRILADA is indicated, 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 psoriatic arthritis.
  • Ankylosing Spondylitis: ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
  • Crohn’s Disease: ABRILADA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
  • Ulcerative Colitis: ABRILADA 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.
  • Plaque Psoriasis: ABRILADA 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. ABRILADA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
  • Hidradenitis Suppurativa: ABRILADA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.
  • Uveitis: ABRILADA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
Please see Full Prescribing Information, including BOXED WARNING, Medication Guide, and Instructions for Use, for ABRILADA.