Alvotech and Teva Pharmaceuticals have secured the US Food and Drug Administration (FDA) approval for Selarsdi (ustekinumab-aekn) as a biosimilar to Johnson & Johnson’s Stelara.
Stelara (ustekinumab) is a human monoclonal antibody (mAb) that selectively targets the p40 protein, which plays a key role in treating immune-mediated diseases.
Selarsdi subcutaneous injection is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children aged six years and above.
Alvotech developed and produced Selarsdi using Sp2/0 cells and a continuous perfusion process, which are the same type of host cell line and process used in the production of Stelara.
Teva US Market Access senior vice president Thomas Rainey said: “The approval of Selarsdi, which is our second biosimilar approval this year, underscores Teva’s commitment to expanding the availability, access and uptake of this important treatment option to patients in the U.S.”
“The biosimilars market is growing, both globally and in the U.S., and biosimilars are a key component of delivering on Teva’s Pivot to Growth strategy.
“The partnership model that we’ve established enables us to leverage our commercial presence and experiences globally as we move to bring additional biosimilars to market.”
In August 2020, Alvotech and Teva signed a strategic partnership for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates.
Last year, the companies extended the collaboration to include two additional biosimilars and new presentations of two previously partnered products.
Selarsdi is the second biosimilar approved under the strategic partnership, following the FDA approval of Simlandi, a high-concentration, citrate-free biosimilar to Humira, in February 2024.
In June last year, Alvotech and Teva signed an agreement with Johnson & Johnson, the manufacturer of the reference biologic Stelara, for its license in the US.
Under the terms of the agreement, Alvotech is responsible for development and manufacturing, and Teva for exclusive commercialization in the US, using its sales and marketing infrastructure.
The FDA approval of Selarsdi was based on a totality of the evidence, including positive analytical and clinical data from the AVT04-GL-301 study and AVT04-GL-101 study.
Alvotech CEO and Chairman Robert Wessman said: “Bringing SELARSDI to market in the U.S. early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in healthcare costs.
“The development of SELARSDI leveraged our purpose-built end-to-end development and manufacturing platform for biosimilars.
“Being able to develop the biosimilar in the same cell type and continuous perfusion process as was used for the reference product, facilitated the development program’s success.”
