New Presentation of Ustekinumab Biosimilar Approved for Crohn’s, Ulcerative Colitis

The FDA has approved an additional presentation of an ustekinumab biosimilar, ustekinumab-aekn (Selarsdi; Alvotech, Teva), expanding the medication’s label to include the treatment of adults with Crohn disease (CD) and ulcerative colitis (UC).¹

“We welcome this step which is fully in line with our plan to align the SELARSDI label with the indications of the reference product, prior to launch next year,” Robert Wessman, Chairman and CEO of Alvotech said in a statement.¹ “We are looking forward to the US launch, after very successful launches of the first biosimilar ustekinumab in Canada, Japan and Europe. This demonstrates our commitment to increasing availability and access to ustekinumab, and other biosimilars in our growing pipeline, for patients worldwide.”

The new presentation is a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion. The new CD and UC indications bring the biosimilar’s list of indications to match that of reference ustekinumab.

The FDA originally approved ustekinumab-aekn in April 2024 in 45 mg/0.5 mL and 90 mg/mL injections in prefilled syringes for subcutaneous use for treating moderate to severe plaque psoriasis and for active psoriatic arthritis (PsA) in adults and pediatric patients 6 years and older.²

Ustekinumab is a monoclonal antibody which binds to the cytokines interleukin (IL)-12 and IL-23 and is the second biosimilar approved by the FDA stemming from Teva and Alvotech’s strategic partnership to collaborate on 7 biosimilars. As per a settlement and license agreement with reference ustekinumab’s manufacturer, Janssen, ustekinumab-aekn is set to enter the US market no later than February 21, 2025.³

“We are thrilled with the expansion of SELARSDI's indications, marking another significant milestone in Teva’s commitment to increasing access to biosimilars in the US,” Thomas Rainey, Senior Vice President, US Biosimilars, added.¹ “This development allows us to serve patients battling gastrointestinal diseases as the US launch of SELARSDI approaches in early 2025. Teva’s dedication to increasing uptake of biosimilars remains steadfast, and we are proud to continue this partnership with Alvotech across a portfolio of 9 partnered products.”

The newly approved presentation adds to the recent body of news concerning ustekinumab biosimilars. Just earlier this month, the FDA approved biosimilar ustekinumab-srlf (IMULDOSA; Accord Biopharma), for all of the reference drug’s indications: psoriasis, PsA, CD, and UC. Ustekinumab-srlf is also expected to launch in the first half of 2025.⁴

"For Accord BioPharma, this is another step forward in our efforts to deliver affordable treatments and satisfy patient needs," Chrys Kokino, US president of Accord, said in a statement.⁴ "The approval of IMULDOSA, our second biosimilar, is evidence of our growing momentum in the industry and our leadership in supporting families with accessible options to address urgent and critical medical conditions."

REFERENCES

1. 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-/

2. Alvotech and Teva announce U.S. FDA approval of SELARSDI^TM (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.

3. 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.

4. Accord BioPharma. FDA Approves IMULDOSA® (ustekinumab-srlf), Accord BioPharma's Biosimilar to STELARA® (ustekinumab), for the Treatment of Chronic Inflammatory Conditions. Press release. PR Newswire. Published October 14, 2024. https://prnmedia.prnewswire.com/news-releases/fda-approves-imuldosa-ustekinumab-srlf-accord-biopharmas-biosimilar-to-stelara-ustekinumab-for-the-treatment-of-chronic-inflammatory-conditions-302274563.html