FDA Approves Selarsdi as Biosimlar to Stelara in an Intravenous Formulation

The FDA has approved ustekinumab-aekn (Selarsdi; Teva Pharmaceuticals), a biosimilar to ustekinumab (Stelara; Janssen Immunology) as a 130 mg/26mL solution in a single-dose vial for intravenous use. The approval further aligns the biosimilar with indications of the reference product for the launch in the US, which is expected in the first quarter of 2025.¹

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“This development allows us to serve patients battling gastrointestinal diseases as the U.S. launch of SELARSDI approaches in early 2025,” Thomas Rainey, senior vice president of US biosimilars at Teva, said in a news release.¹

In April 2024, the FDA approved ustekinumab-aekn as a subcutaneous injection for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric individuals 6 years and older. The initial approval was based on data from the Study AVT04-GL-301 and Study AVT04-GL-101 (NCT04744363) trials. There were 581 individuals included from 4 countries in Europe. Investigators used the Psoriasis Area and Severity Index to determine the percent improvement from baseline to week 12. There were 2 phases of the study: a primary efficacy assessment (day 1 to week 15) and a long-term efficacy and safety assessment (from week 16 to week 52).²

Patients received either an initial dose of the biosimilar in the 45 mg strength followed by another dose 4 weeks later or received a loading dose of Stelara followed by another dose 4 weeks later. For stage 2, individuals either continued to receive the biosimilar every 12 weeks, switched to receive the biosimilar every 12 weeks, or continued on Stelara every 2 weeks.²

For Study AVT04-GL-101, investigators compared the pharmacokinetics, safety, tolerability, and immunogenicity for the biosimilar subcutaneous injection and both the United States-licensed and European Union-approved Stelara formulations. This study included 294 healthy adults from Australia and New Zealand who received the biosimilar, the US formulation of Stelara, or the EU Stelara formulation on day 1.²

Furthermore, the FDA also approved 3 other Stelara biosimilars, including ustekinumab-ttwe (Pyzchiva; Sandoz, Samsung Bioepis) for all Stelara indications in July 2024, ustekinumab-aauz (Otulfi; Fresenius Kabi) for Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis in October 2024, and ustekinumab-srlf (Imuldosa; Accord BioPharma) for chronic inflammatory conditions in October 2024.^3-5

Ustekinumab is a human monoclonal antibody targeting p40 protein, which plays a role in treating immune-mediated diseases. The biosimilar formulation uses Sp2/0 cells and continuous perfusion, the same type of host cell used for Stelara.²

REFERENCES

1. Alvotech and Teva Announce US FDA Approval of Additional Presentation of Selarsdi (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara (ustekinumab). News release. Teva. October 22, 2024. Accessed October 22, 2024. https://www.tevausa.com/news-and-media/press-releases/alvotech-and-teva-announce-u.s.-fda-approval-of-additional-presentation-of-selarsdi-ustekinumab-aekn-/

2. Gallagher A. FDA Approves Ustekinumab Biosimilar to Stelara for Treatment of Plaque Psoriasis. Pharmacy Times. April 17, 2024. Accessed October 22, 2024. https://www.pharmacytimes.com/view/fda-approves-ustekinumab-biosimilar-to-stelara-for-treatment-of-plaque-psoriasis

3. Gallagher A. FDA Approves Ustekinumab-ttwe as Biosimilar to Stelara. Pharmacy Times. July 1, 2024. Accessed October 22, 2024. https://www.pharmacytimes.com/view/fda-approves-ustekinumab-ttwe-as-biosimilar-to-stelara

4. Gallagher A. FDA Approves Ustekinumab-Aauz as Biosimilar for Stelara. Pharmacy Times. October 1, 2024. Accessed October 22, 2024. https://www.pharmacytimes.com/view/fda-approves-ustekinumab-aauz-as-biosimlar-for-stelara

5. McGovern G. FDA Approves Imuldosa, Stelara Biosimilar For Treatment of Chronic Inflammatory Conditions. Pharmacy Times. October 15, 2024. Accessed October 22, 2024. https://www.pharmacytimes.com/view/fda-approves-imuldosa-ustekinumab-biosimilar-for-treatment-of-chronic-inflammatory-conditions