Teva and Alvotech Announce SIMLANDI® (adalimumab-ryvk) Injection Now Available in the U.S.
Teva Pharmaceuticals and Alvotech have announced the U.S. launch of SIMLANDI (adalimumab-ryvk) injection, an interchangeable biosimilar to Humira. This product is the first high-concentration, citrate-free biosimilar approved by the FDA. SIMLANDI is indicated for treating multiple conditions including adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, and more. The launch aims to provide cost savings and improved access to patients and healthcare providers. The companies entered a strategic partnership in 2020, focusing on commercializing biosimilars in the U.S. market. Teva handles commercialization, while Alvotech manages development and manufacturing.
- SIMLANDI is the first high-concentration, citrate-free biosimilar to Humira approved by the FDA.
- SIMLANDI's launch can potentially reduce healthcare costs for providers and patients.
- Teva and Alvotech's strategic partnership strengthens with the addition of new biosimilars.
- SIMLANDI covers a broad range of conditions including adult rheumatoid arthritis and Crohn's disease.
- Teva's extensive sales and marketing infrastructure supports the commercialization.
- Market competition with existing Humira biosimilars.
- Dependency on FDA approval for new products.
- Potential market access challenges despite strategic partnerships.
Insights
The launch of SIMLANDI as a high-concentration, citrate-free biosimilar to Humira is a significant milestone in the field of biologics. Biosimilars are products that are highly similar to FDA-approved biologic products, known as reference products and are expected to have the same clinical effect. The interchangeability designation means that SIMLANDI can be substituted for Humira without the need for a prescriber to explicitly authorize the switch, which can drive cost savings and increase accessibility for patients.
The citrate-free formulation is particularly notable because it can reduce the discomfort associated with injections. Humira being widely prescribed in its high-concentration form underscores the potential impact SIMLANDI could have in capturing a significant market share, thereby offering a cost-effective alternative. These features would likely benefit patients suffering from a variety of autoimmune diseases, providing them with more options.
Overall, this launch not only benefits patients through reduced costs and improved comfort but also positions Teva and Alvotech as strong competitors in the biosimilars market.
From a financial perspective, the introduction of SIMLANDI is compelling. Humira is one of the best-selling drugs globally, so having a biosimilar with interchangeability status could significantly impact the revenues of Teva and Alvotech. Interchangeable biosimilars can be substituted at the pharmacy level, which could drive rapid uptake and reduce market share for the original product, Humira.
Teva's strategic partnership with Alvotech, which includes exclusive commercialization rights in the U.S., leverages Teva's extensive sales and marketing infrastructure. This partnership is likely to provide a robust platform for further biosimilar launches, potentially leading to sustained revenue growth. The market's positive reception of SIMLANDI would be a key indicator of the success of this collaboration.
Financially, this launch represents a significant opportunity for cost savings in the healthcare system and potential revenue growth for Teva and Alvotech, making it a notable event for investors to watch.
The availability of SIMLANDI in the U.S. market presents an interesting shift in the biosimilars landscape. Humira has long been a cornerstone treatment for various autoimmune conditions and a high-concentration, citrate-free biosimilar could see substantial adoption. The fact that nearly 88% of U.S. prescriptions for adalimumab are for the high-concentration form could make SIMLANDI a direct competitor with significant market potential.
Teva and Alvotech's proactive approach to working with payors to ensure access to SIMLANDI indicates a strategic move to secure market penetration. The emphasis on cost-effectiveness and reduced inflationary pressures in healthcare aligns well with current market demands, which are increasingly focused on affordable treatments without compromising quality.
In the long term, the success of SIMLANDI could pave the way for other biosimilars under development by Teva and Alvotech, thereby disrupting the market dominance of existing biologics and biosimilars. This could lead to a healthier competitive landscape, ultimately benefiting patients and providers alike.
- SIMLANDI is the first interchangeable high-concentration, citrate-free biosimilar to Humira®
“We are proud to make SIMLANDI available in the
SIMLANDI is approved by the
“It is a great pleasure to be able to offer
Teva and Alvotech entered into a strategic partnership for the exclusive commercialization of five of Alvotech’s biosimilar product candidates in August 2020, and in July 2023, the collaboration was extended to include two additional biosimilars and new presentations of two previously partnered products. Alvotech handles development and manufacturing, while Teva is responsible for the exclusive commercialization in the
Use of Trademarks
Humira is a registered trademark of AbbVie Biotechnology Ltd.
Stelara is a registered trademark of Johnson & Johnson.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com.
About Alvotech
Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech’s current pipeline includes eight disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include
IMPORTANT SAFETY INFORMATION FOR SIMLANDI (adalimumab-ryvk) injection
INDICATIONS
SIMLANDI® (adalimumab-ryvk) injection, is a tumor necrosis factor (TNF)-blocker indicated for:
- Rheumatoid Arthritis (RA): Alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic 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 RA.
- Juvenile Idiopathic Arthritis (JIA): Alone or in combination with methotrexate for reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
- Psoriatic Arthritis (PsA): 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 PsA.
- Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS.
- Crohn’s Disease (CD): Treatment of moderately to severely active CD in adults and pediatric patients 6 years of age and older.
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Ulcerative Colitis (UC): Treatment of moderately to severely active UC 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 (Ps): The treatment of adult patients with moderate to severe chronic Ps who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. SIMLANDI should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
- Hidradenitis Suppurativa (HS): The treatment of moderate to severe HS in adult patients.
- Uveitis: The treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
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
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here for full Prescribing Information for SIMLANDI, including BOXED WARNINGS and Medication Guide.
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 Alvotech; our ability to successfully commercialize SIMLANDI in the
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 Alvotech and may include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, and market launches. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential”, “aim” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the outcome of any legal proceedings that may be instituted against Alvotech or others following the business combination between Alvotech Holdings S.A., Oaktree Acquisition Corp. II and Alvotech; (2) the ability to raise substantial additional funding, which may not be available on acceptable terms or at all; (3) the ability to maintain stock exchange listing standards; (4) changes in applicable laws or regulations; (5) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (6) Alvotech’s estimates of expenses and profitability; (7) Alvotech’s ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (8) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or future regulatory approvals or marketing authorizations; (9) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (10) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (11) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (12) the ability of Alvotech’s partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (13) Alvotech’s ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (14) the success of Alvotech’s current and future collaborations, joint ventures, partnerships or licensing arrangements; (15) Alvotech’s ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (16) Alvotech’s ability to manufacture sufficient commercial supply of its approved products; (17) the outcome of ongoing and future litigation regarding Alvotech’s products and product candidates; (18) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, war in
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Media
Kelley Dougherty
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IR
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Sanjeev Sharma
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Source: Teva Pharmaceutical Industries Limited
FAQ
What is SIMLANDI (adalimumab-ryvk)?
When was SIMLANDI launched in the U.S.?
What conditions does SIMLANDI treat?
What is the significance of SIMLANDI being citrate-free?
Who are the partners involved in SIMLANDI's commercialization?
What makes SIMLANDI unique compared to other Humira biosimilars?
