Ustekinumab-aekn Now Interchangeable With Reference for PsA, PsO, CD, UC

Ustekinumab-aekn (Selarsdi) has received the interchangeable designation with the reference biologic ustekinumab (Stelara), as of April 30, 2025, for treating adults and pediatric with psoriatic arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis.1

"The FDA’s confirmation of full interchangeability for SELARSDI is an important development for patients and providers seeking to expand access to this important treatment," Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva, said in a statement.1 "Teva’s recent launch of 2 biosimilars – SELARSDI and EPYSQLI – coupled with a rich pipeline of assets expected to launch over the next few years, position Teva to establish a strong leadership position in the growing landscape of biosimilars and to drive growth for the company as it embarks on the next phase of its strategy."

The FDA originally approved ustekinumab-aekn in 45 mg/0.5 mL and 90 mg/mL subcutaneous injection and prefilled syringe formulations in April 2024 before approving 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 in December 2024.2,3 after exclusivity expires for the first interchangeable biosimilar on April 30, 2025.

“Interchangeability of SELARSDI with Stelara will further enable increased access for U.S. patients to more affordable treatment options and contribute to lowering healthcare costs, which is an important part of our mission as a leading developer and manufacturer of biosimilars globally,” Anil Okay, Chief Commercial Officer for Alvotech, added to the statement.1 “With 2 important biosimilars on the U.S. market and Biologics License Applications for 3 new biosimilar candidates under FDA review, Alvotech continues to rapidly expand its portfolio of high-quality biologics based on a fully integrated approach to development and manufacturing, coupled with a unique focus on biosimilars.”

Ustekinumab is a human monoclonal antibody (mAb) that selectively targets the p40 protein, a component of interleukin (IL)-12 and IL-23 cytokines, which play crucial roles in treating immune-mediated and inflammatory. Alvotech notes that it develops 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.

“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,” Rainey said in an earlier statement.4 “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.”

REFERENCES

1. Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (ustekinumab). May 5, 2025. https://www.globenewswire.com/news-release/2025/05/05/3073976/0/en/Teva-and-Alvotech-Announce-FDA-Approval-of-Interchangeability-for-SELARSDI-ustekinumab-aekn-with-Stelara-ustekinumab.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-/

4. 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