New Biosimilar, Ustekinumab-aekn, Now Available in U.S.

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Ustekinumab-aekn (Selarsdi) injection is now available in the United States for the treatment of psoriatic arthritis (PsA), plaque psoriasis (PsO), Crohn disease (CD), ulcerative colitis (UC), pediatric plaque psoriasis and pediatric psoriatic arthritis.¹

Ustekinumab-aekn in its 4 presentations will be interchangeable with the reference biologic ustekinumab for all its approved indications after exclusivity expires for the first interchangeable biosimilar on April 30, 2025.

“Biosimilars like SELARSDI create opportunities for cost savings across the healthcare system, and we are proud to be able to introduce our second biosimilar treatment option in partnership with Alvotech to U.S. patients and providers,” Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva, said in a statement.¹ “The U.S. availability of SELARSDI reinforces Teva’s overall strategy to identify strategic business partners to develop and manufacture biosimilars while leveraging Teva’s commercial presence and experience to bring this and other products to the U.S. market.”

The FDA originally approved ustekinumab-aekn in its 45 mg/0.5 mL and 90 mg/mL subcutaneous injection and prefilled syringe formulations for treatment of moderate to severe PsO and active PsA in both adults and pediatric patients aged at least 6 years in April 2024.²

In December 2024, the FDA approved an additional 130 mg/26 mL (5 mg/mL) solution in a single-dose vial intravenous infusion formulation, expanding the medication’s label to include the treatment of adults with UC and CD.³

“The U.S. launch of SELARSDI is an important step for our partnership and reaffirms a joint commitment to providing more affordable treatment options for U.S. patients,” Anil Okay, Chief Commercial Officer for Alvotech, added.¹ “Alvotech’s fully integrated approach to development and manufacturing, coupled with our focus on biosimilars, enables us to continue expanding a portfolio of high-quality biologics and contribute meaningfully to lowering healthcare costs world-wide.”

Ustekinumab is a human monoclonal antibody (mAb) that selectively targets the p40 protein, a component common to both interleukin (IL)-12 and IL-23 cytokines, which play crucial roles in treating immune-mediated diseases like PsO and PsA and inflammatory diseases like CD and UC. Alvotech developed and produces ustekinumab-aekn using the same type of host cell line and process (Sp2/0 cells and a continuous perfusion process) as reference ustekinumab.

REFERENCES

1. Teva and Alvotech Announce SELARSDI™ (ustekinumab-aekn) Injection Now Available in the U.S. News release. Alvotech. February 20, 2025. https://www.globenewswire.com/news-release/2025/02/21/3030307/0/en/Teva-and-Alvotech-Announce-SELARSDI-ustekinumab-aekn-Injection-Now-Available-in-the-U-S.html

2. Alvotech and Teva announce U.S. FDA approval of SELARSDI (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab). Teva Pharmaceutical Industries Ltd. - Alvotech and Teva Announce U.S. FDA Approval of SELARSDI (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.

3. Alvotech and Teva Announce U.S. FDA Approval of Additional Presentation of SELARSDI™ (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara® (ustekinumab). News release. Alvotech. 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-/