Alvotech and Teva Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira®
-
SIMLANDI is the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the
U.S. -
SIMLANDI is the first biosimilar approval under the strategic partnership between
Alvotech and Teva in the U.S. market -
SIMLANDI will qualify for interchangeable exclusivity in the
U.S. for some concentration strengths
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240223653457/en/
SIMLANDI is the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA, and will qualify for interchangeable exclusivity for the 40mg/0.4ml injection. While both low-concentration and high-concentration strength biosimilars of Humira are marketed in the
An interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber, much like generic drugs are routinely substituted for brand name drugs. As the only interchangeable adalimumab biosimilar with the high-concentration formulation, SIMLANDI can be substituted for Humira at the pharmacy level, subject to state pharmacy laws.
"The approval of SIMLANDI marks the first high-concentration, citrate-free biosimilar to Humira with IC status,” said Dr.
In
The FDA approval of SIMLANDI was based on a totality of evidence, including analytical, non-clinical, and clinical data. The clinical development program, included data from (i) AVT02-GL-101, a Phase I, multicenter, randomized, double blind, 3-arm study, to demonstrate pharmacokinetic (PK) similarity and compare safety and tolerability of SIMLANDI to Humira in healthy adult volunteers; (ii) AVT02-GL-301, Phase III, multicenter, double-blind, randomized, parallel-group active control study to demonstrate similar efficacy, and compare safety and immunogenicity of AVT02 versus Humira in patients with moderate-to-severe chronic plaque psoriasis and (iii) AVT02-GL-302, a Phase III, multicenter, randomized, double-blind, parallel-group study in moderate to severe chronic plaque psoriasis patients to demonstrate similar PK, and comparable efficacy, safety, and immunogenicity between patients receiving Humira and patients undergoing repeated switches between Humira and SIMLANDI.
Sources
[1] (AbbVie Full-Year and Fourth Quarter 2023 Financial Results): https://investors.abbvie.com/static-files/831c0d3d-8813-4942-b7af-a3dade33bea5
[2] Based on sales data from Symphony
Use of Trademarks
Humira® is a registered trademark of
About
About Teva
INDICATIONS FOR SIMLANDI (adalimumab-ryvk) injection
SIMLANDI is a tumor necrosis factor (TNF) blocker indicated for:
- Rheumatoid Arthritis (RA): 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 RA. SIMLANDI can be used alone or in combination with methotrexate or other nonbiologic disease-modifying anti-rheumatic drugs (DMARDs).
- Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. SIMLANDI can be used alone or in combination with methotrexate.
- Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. SIMLANDI can be used alone or in combination with non-biologic DMARDs.
- Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS.
- Crohn’s Disease (CD): Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.
- Ulcerative Colitis (UC): Treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
- Plaque Psoriasis (Ps): 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.
- Hidradenitis Suppurativa (HS): Treatment of moderate to severe hidradenitis suppurativa in adult patients (1.8)
- Uveitis (UV): Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients (1.9)
IMPORTANT SAFETY INFORMATION
WARNING: SERIOUS INFECTIONS and MALIGNANCY
SERIOUS INFECTIONS
Patients treated with adalimumab products, including SIMLANDI, 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 SIMLANDI 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 pulmonary or extrapulmonary disease. Evaluate patients for tuberculosis risk factors and test for latent TB before initiating SIMLANDI and periodically during therapy. Initiate treatment for latent TB prior to SIMLANDI 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 SIMLANDI 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 SIMLANDI, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
- Do not start SIMLANDI during an active infection, including localized infections
- Patients 65 years of age and older, 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 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 SIMLANDI 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.
MALIGNANCY
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 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 TNF blocker-treatment, including SIMLANDI, prior to initiating therapy in patients with known malignancy.
- 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 SIMLANDI.
-
In the 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 a higher risk than the general population for the development of lymphoma, even in the absence of TNF blockers. - Postmarketing cases of acute and chronic leukemia have been reported in association 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 represented a variety of different malignancies and included rare malignancies associated with immunosuppression and malignancies that are not usually observed in children and adolescents.
Hypersensitivity Reactions
Anaphylaxis or serious allergic reactions have been reported following administration of adalimumab products. If an anaphylactic or other serious hypersensitivity reaction occurs, immediately discontinue administration of SIMLANDI and institute appropriate therapy.
Hepatitis B Virus Reactivation
- Use of TNF blockers, including SIMLANDI, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases with HBV reactivation occurring in conjunction with TNF blocker therapy 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 identified as carriers of HBV and closely monitor during and after SIMLANDI treatment.
- In patients who develop HBV reactivation, stop SIMLANDI and initiate effective anti-viral therapy. Exercise caution when resuming SIMLANDI after HBV treatment.
Neurologic Reactions
- Use of TNF blocking agents, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating disease, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome.
- Exercise caution when considering SIMLANDI for patients with these disorders; discontinuation of SIMLANDI should be considered if any of these disorders develop.
- There is a known association between intermediate uveitis and central demyelinating disorders.
Hematological Reactions
- Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blocking agents. Medically significant cytopenia has been infrequently reported with adalimumab products.
- Advise patients to seek medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor).
- Consider stopping SIMLANDI if significant hematologic abnormalities occur.
Heart Failure
Worsening and new onset congestive heart failure (CHF) have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products; exercise caution when using SIMLANDI in patients who have heart failure and monitor them carefully.
Autoimmunity
Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
Immunizations
- Patients on SIMLANDI should not receive live vaccines.
- Pediatric patients, if possible, should be brought up to date with all immunizations prior to initiating SIMLANDI 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.
ADVERSE REACTIONS
The most common adverse reactions (greater than or equal to 10%): are infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash.
To report SUSPECTED ADVERSE REACTIONS, contact
Please click here for full Prescribing Information for SIMLANDI, including BOXED WARNINGS and Medication Guide.
ALVOTECH Forward Looking Statements
Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial operating performance of
TEVA Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our strategic partnership with
View source version on businesswire.com: https://www.businesswire.com/news/home/20240223653457/en/
CONTACTS FOR THE MEDIA AND IR
Investor Relations and
alvotech.ir@alvotech.com
TEVA
IR Contacts
PR Contacts
Source: