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Arthritis Treatment Enhanced with Teva and Alvotech’s Launch of SIMLANDI, a Humira Biosimilar

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In a significant move aimed at broadening access to biosimilars, Teva and Alvotech have launched SIMLANDI for arthritis treatment in the United States. This development marks the first biosimilar product introduced under their strategic partnership. SIMLANDI, a high-concentration, citrate-free injection biosimilar to Humira, has received the Food and Drug Administration (FDA) approval for interchangeability exclusivity for the 40mg/0.4ml formulation. This launch underscores the growing importance of biosimilars in offering cost-effective therapeutic options for patients.

The FDA has approved SIMLANDI as the first high-concentration, citrate-free biosimilar to Humira with interchangeability exclusivity. This approval is significant as it paves the way for treating various adult inflammatory conditions. These conditions include rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and Crohn’s disease, among others. The approval ensures that patients suffering from these chronic conditions have access to more affordable treatment options.

Teva and Alvotech signed a strategic collaboration in August 2020 to exclusively commercialize five biosimilar product candidates developed by Alvotech. This collaboration was expanded in July last year to include two additional biosimilars and new presentations of previously collaborated products. Teva handles the exclusive commercialization of these products in the US, leveraging its robust sales and marketing capabilities to ensure successful market penetration.

Teva and Alvotech Partnership Successfully Launches SIMLANDI and SELARSDI Biosimilars in the US Market

Under this partnership, Alvotech is tasked with the development and manufacturing of biosimilars, while Teva focuses on their commercialization in the US market. This strategic collaboration aims to overcome market barriers and ensure that these biosimilars reach a broader patient base. The partnership leverages Teva’s extensive sales and marketing infrastructure to ensure the successful launch and distribution of SIMLANDI.

In April, the FDA approved SELARSDI (ustekinumab-aekn) injection, another biosimilar developed by Alvotech, intended for treating moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients aged six years and older. This approval further highlights the success of the Teva-Alvotech collaboration in bringing effective biosimilar products to market.


Teva and Alvotech’s Launch of SIMLANDI Enhances Arthritis Treatment and Reduces Healthcare Costs

SIMLANDI offers a high-concentration, citrate-free formulation, improving patient comfort and compliance. Interchangeability exclusivity with Humira ensures that SIMLANDI can be substituted without clinical concerns. The partnership between Teva and Alvotech aims to introduce six more biosimilars to the US market by 2027. Biosimilars like SIMLANDI provide significant cost savings across the healthcare system, benefiting both patients and providers.

The strategic partnership between Teva and Alvotech represents a critical step in expanding the availability of high-quality biosimilars in the US market. By leveraging Teva’s marketing capabilities and Alvotech’s development expertise, the two companies are well-positioned to address the growing demand for cost-effective therapeutic options. The launch of SIMLANDI not only offers relief for patients with chronic inflammatory conditions but also underscores the potential for biosimilars to drive down healthcare costs. As the collaboration progresses, the healthcare community can expect to see more innovative and accessible treatments reaching the market, ultimately enhancing patient care and outcomes.


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Resource: Alvotech, May 20, 2024

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