FDA Approves Biosimilar Ustekinumab-aekn for PsO, PsA

Credit: US Food and Drug Administration

Alvotech and Teva announced the US Food and Drug Administration (FDA) approval of its ustekinumab (Stelara) biosimilar, ustekinumab-aekn (Selardsi), for the treatment of moderate to severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA) in both adults and pediatric patients aged ≥ 6 years.¹

“The approval of Selardsi–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 US,” Thomas Rainey, Senior Vice President, US Market Access at Teva, said in a statement.¹ “The biosimilars market is growing, both globally and in the US, 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.”

The companies, both of whom anticipated market entry in Canada in Q1 2024, have already been granted regulatory approval in Japan, Canada, and in the European Economic Area (EEA).²

The biosimilar, a monoclonal antibody, binds to the cytokines interleukin (IL)-12 and IL-23, both of which are involved in treating immune-mediated diseases like PsO and PsA.

The subcutaneous formulation is the second biosimilar approved by the FDA stemming from Teva and Alvotech’s strategic partnership to collaborate on 7 biosimilars.

The biosimilar is expected to be marketed in the US on or after February 21, 2025.

“Bringing SELARSDI to market in the US 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,” Robert Wessman, Chairman and CEO of Alvotech, added.¹ “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.”

References

1. ^{Alvotech and Teva announce U.S. FDA approval of SELARSDITM (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab). Teva Pharmaceutical Industries Ltd. - Alvotech and Teva Announce U.S. FDA Approval of SELARSDITM (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab). Accessed April 16, 2024. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/Alvotech-and-Teva-Announce-U.S.-FDA-Approval-of-SELARSDI-ustekinumab-aekn-biosimilar-to-Stelara-ustekinumab/default.aspx.}
2. ^{Alvotech announces expected global market entry dates for AVT04 biosimilar to Stelara® (ustekinumab). Alvotech. February 15, 2024. Accessed April 16, 2024. https://investors.alvotech.com/news-releases/news-release-details/alvotech-announces-expected-global-market-entry-dates-avt04.}