Stelara Biosimilar Ustekinumab-aekn Recieves FDA Approval

The FDA has approved ustekinumab (Stelara) biosimilar ustekinumab-aekn (Selarsdi) to treat moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children aged 6 years and older. This approval marks the second biosimilar approval for the strategic partnership between Alvotech and Teva.¹

Ustekinumab is a human monoclonal antibody that selectively targets the p40 protein, a common component of interleukin-12 (IL-12) and IL-23—both of which play crucial rules in the treatment of immune mediated diseases.

FDA approval was based on both analytical and clinical data. A clinical development program for the drug included data from 2 studies: the randomized, double-blind, multicenter, 52-week AVT04-GL-301 study (NCT04930042) and ATV04-GL-101 (NCT04744363), a phase 1, randomized, double-blind, single-dose, parallel-group, 3-arm study comparing pharmacokinetic, safety, tolerability, and immunogenicity profiles of the biosimilar vs the reference product.

Alvotech and Teva announced in June 2023 that a settlement and license agreement had been reached with Johnson & Johnson, who manufacture ustekinumab.

READ MORE: FDA: Simlandi Becomes Third Interchangeable Humira Biosimilar After Approval

Alvotech and Teva entered their strategic partnership for exclusive commercialization of 5 Alvotech biosimilar product candidates in August 2020. In August 2023, this partnership was expanded to include 2 additional biosimilars. Ustekinumab-aekn is the second biosimilar approved through this partnership; the first approval was adalimumab biosimilar AVT02 (Simlandi), the tenth biosimilar product referencing adalimumab (Humira).

Sales of reference product ustekinumab were “nearly $7 billion in 2023,” according to a Teva press release. Ustekinumab-aekn will create opportunities for cost savings, while providing additional treatment options for patients.

Alvotech is also working to develop biosimilars for golimumab (Simponi and Simponi Aria), aflibercept (Eylea), and denosumab (Prolia/Xgeva).²

READ MORE: Biosimilars Resource Center

References

1. Alvotech and Teva announce US FDA approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab). News release. Teva. April 16, 2024. Accessed April 19, 2024. https://www.tevapharm.com/news-and-media/latest-news/alvotech-and-teva-announce-u.s.-fda-approval-of-selarsdi-ustekinumab-aekn-biosimilar-to-stelara-ust

2. Jeremias S. Alvotech’s Stelara biosimilar, Selarsdi, receives FDA approval. The Center for Biosimilars. April 16, 2024. Accessed April 19, 2024. https://www.centerforbiosimilars.com/view/alvotech-s-stelara-biosimilar-selarsdi-receives-fda-approval