FDA Grants Interchangeable Designation to Pfizer’s Biosimilar ABRILADA™
• ABRILADA is one of only two biosimilars that are interchangeable with Humira®
• Interchangeable designation supported by positive data from the REFLECTIONS B538-12 study
NEW YORK, October 5, 2023 – Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has designated ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The interchangeable designation applies to all approved indications of ABRILADA, including certain patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.
“With this designation, ABRILADA is now both biosimilar to and interchangeable with Humira, reinforcing confidence among physicians and pharmacists that there is no decrease in effectiveness or increase in safety risk associated with switching between ABRILADA and the reference product,” said Roy Fleischmann, MD, Clinical Professor of Medicine, University of Texas Southwestern Medical Center.
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.
“ABRILADA was developed with patients in mind, and having an interchangeable designation is a key step toward potentially increasing their access to this important treatment option,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer. “With 15 years of global in market experience in biosimilars and an industry-leading seven marketed biosimilar products in the U.S., Pfizer continues to expand options for patient care by introducing ABRILADA.”
The interchangeable designation was supported by data from the Phase 3 REFLECTIONS B538-12 study, which demonstrated similar outcomes in terms of pharmacokinetics, safety and immunogenicity in patients with moderately to severely active RA who switched multiple times between treatment with the 40 mg/0.8 mL concentration of ABRILADA and the 40 mg/0.4 mL concentration of Humira, compared to patients who received continuous Humira, each taken in combination with methotrexate. Results from this study were recently published in The Lancet Rheumatology.
Biosimilars play an important role in the treatment of a variety of life-threatening and chronic conditions, offering a solution that can help transform patient care by improving access to critical, widely prescribed medicines. Biosimilars also provide value to healthcare systems by driving market competition that may lower the cost of care.
ABRILADA will be available later this year at two price points, with the goal of achieving the broadest possible access for patients. Starting in late October 2023, ABRILADA will be available at a list price (Wholesale Acquisition Cost) 5% below the Humira list price. Later in 2023, ABRILADA will be available at a second list price 60% below the Humira list price.
About ABRILADA (adalimumab-afzb)
ABRILADA is a citrate-free biosimilar to Humira that received FDA approval in 2019. The FDA approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of ABRILADA to the reference product. This includes results from the REFLECTIONS B538-02 clinical comparative study, which found no clinically meaningful differences in efficacy, safety or immunogenicity of ABRILADA compared to the reference product, each taken in combination with methotrexate, in patients with moderately to severely active RA.
IMPORTANT SAFETY INFORMATION for ABRILADA (adalimumab-afzb)
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.
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.
• Post-marketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the post-marketing 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.
• Rheumatoid Arthritis: ABRILADA is indicated, alone or in combination with methotrexate or other non-biologic 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.
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DISCLOSURE NOTICE: The information contained in this statement is as of October 5, 2023. Pfizer assumes no obligation to update forward-looking statements contained in this statement as the result of new information or future events or developments.
This statement contains forward-looking information about ABRILADA (adalimumab-afzb), including its potential benefits and expected launch timing in the U.S., that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the timing of availability and commercial success of ABRILADA in the United States; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when applications for ABRILADA may be filed in any other jurisdictions; whether and when any applications for ABRILADA that may be pending or filed may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether ABRILADA will be commercially successful; intellectual property and/or litigation implications; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of ABRILADA; uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate coverage/reimbursement access or remains in a disadvantaged position relative to the innovator product; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available www.sec.gov and www.pfizer.com.
Humira® is a registered trademark of AbbVie Biotechnology Ltd.
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