Four Years of Real-World Experience in More Than 300,000 Patients and Over 60 Countries1
THOUSAND OAKS, Calif., Jan. 31, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced AMJEVITA™ (adalimumab-atto), a biosimilar to Humira®* (adalimumab), is now available in the United States. AMJEVITA was the first biosimilar to Humira approved by the U.S. Food and Drug Administration (FDA), in 2016.2,3
"With today's announcement, AMJEVITA is the first U.S. biosimilar to Humira®, a medicine used by more than a million patients living with certain serious inflammatory diseases," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "With our track record of developing and manufacturing biologics and decades of experience in inflammation, Amgen is uniquely equipped to supply this biosimilar medicine while reducing costs."
"Biosimilars are extensively studied, FDA-approved treatments that have the potential to reduce costs to the healthcare system," said Steven Taylor, president and chief executive officer at the Arthritis Foundation. "AMJEVITA provides another treatment option for patients and their doctors."
AMJEVITA (40 mg) is available at a list price (Wholesale Acquisition Cost) 55% below the current Humira list price. AMJEVITA is also available at a list price 5% below the current Humira list price. Amgen's goal is to provide broad access for patients by offering two options to health plans and pharmacy benefit managers. More information on Amgen's approach to responsible pricing is on the company's website.
Like Humira's citrate-free formulation that is associated with less pain at the injection site, AMJEVITA is citrate-free.2,4 AMJEVITA will be available in prefilled syringe and autoinjector presentations to support dosing in each of the approved indications. Amgen offers patient support, such as financial support information and educational resources, through AMJEVITA SupportPlus. To learn more, visit AMJEVITA.com.
Amgen currently has 11 biosimilar medicines in market or under development. Five are FDA-approved in the U.S. and three are approved in the European Union.
About AMJEVITA™ (adalimumab-atto)
AMJEVITA is a biosimilar to Humira®* (adalimumab), an anti-TNF-α monoclonal antibody. The active ingredient of AMJEVITA is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as Humira. AMJEVITA is approved to treat seven inflammatory diseases including moderate-to-severe rheumatoid arthritis in adults, moderate-to-severe polyarticular juvenile idiopathic arthritis in patients 2 years of age and older, psoriatic arthritis in adults, ankylosing spondylitis in adults, moderate-to-severe chronic plaque psoriasis in adults, moderate-to-severe Crohn's disease in adults and pediatric patients 6 years of age and older and moderate-to-severe ulcerative colitis in adults.2 AMJEVITA outside the U.S. is marketed as AMGEVITA® (adalimumab) and has been prescribed to more than 300,000 patients in over 60 countries.
*Humira® is a registered trademark of AbbVie, Inc.
In the U.S., AMJEVITA is indicated 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, alone or in combination with methotrexate or other non-biologic DMARDs.
- reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older, alone or in combination with methotrexate.
- reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis, alone or in combination with non-biologic DMARDs.
- reducing signs and symptoms in adult patients with active ankylosing spondylitis.
- the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
- the treatment of moderately to severely active ulcerative colitis in adult patients. The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.
- 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. AMJEVITA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
AMJEVITA™ U.S. Important Safety Information
Patients treated with AMJEVITA 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 AMJEVITA 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 AMJEVITA use and during therapy. Initiate treatment for latent TB prior to AMJEVITA 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 AMJEVITA 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 AMJEVITA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
- Do not start AMJEVITA 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 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 AMJEVITA with other biologic 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. Postmarketing 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 of these patients had received treatment with azathioprine or 6-mercaptopurine 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 AMJEVITA prior to initiating or continuing therapy in a patient with known malignancy.
- In clinical trials of some TNF blockers, including adalimumab products, more cases of malignancies were observed among TNF-blocker-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 PUVA therapy, for the presence of NMSC prior to and during treatment with AMJEVITA.
- 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.
Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If a serious allergic reaction occurs, stop AMJEVITA and institute appropriate therapy.
HEPATITIS B VIRUS REACTIVATION
Use of TNF blockers, including AMJEVITA, 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 AMJEVITA treatment. Discontinue AMJEVITA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming AMJEVITA 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 AMJEVITA for patients with these disorders; discontinuation of AMJEVITA should be considered if any of these disorders develop.
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 AMJEVITA if significant hematologic abnormalities occur.
CONGESTIVE HEART FAILURE
Worsening or 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 AMJEVITA should not receive live vaccines. Pediatric patients, if possible, should be brought up to date with all immunizations before initiating AMJEVITA 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 adalimumab products 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.
Please see the accompanying AMJEVITA full Prescribing Information, including Medication Guide.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2022, Amgen was named one of the "World's Best Employers" by Forbes and one of "America's 100 Most Sustainable Companies" by Barron's.
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CONTACT: Amgen, Thousand Oaks
Michael Strapazon, 805-313-5553 (media)
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- Data on File. Amgen. 2022.
- AMJEVITA U.S. prescribing information. Available at: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Amjevita/amjevita_pi_hcp_english.pdf [Last accessed: January 2023]
- Food and Drug Administration. FDA approves Amjevita, a biosimilar to Humira. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-amjevita-biosimilar-humira. Last accessed January 2023.
- Nash P, et al. Randomized Crossover Comparison of Injection Site Pain with 40 mg/0.4 or 0.8 mL Formulations of Adalimumab in Patients with Rheumatoid Arthritis. Rheumatol Ther. 2016 Dec; 3 (2): 257-270.
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