FDA expands approval of Stelara biosimilar Selarsdi to include UC, Crohn’s disease
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Key takeaways:
- Selarsdi, an ustekinumab biosimilar, is now approved Crohn’s disease and ulcerative colitis.
- The drug is expected to be available in the U.S. in early 2025.
The FDA approved the Stelara biosimilar, Selarsdi, as a 130 mg/26 mL single-dose IV infusion for adult patients with Crohn’s disease and ulcerative colitis, Alvotech and Teva Pharmaceuticals announced in a press release.
The agency had previously approved 45 mg/0.5 mL and 90 mg/mL subcutaneous formulations of Selarsdi (ustekinumab-aekn) for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis. With this expanded approval, Selarsdi further reinforced its position as a contender with other Stelara (ustekinumab, Janssen) biosimilars expected to flood the market in early 2025.
“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 the press release. “We are looking forward to the U.S. 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.”
Alvotech and Teva reported that they have entered a license agreement with Janssen, which would allow the companies to launch Selarsdi in the U.S. market no later than February 21, 2025.
“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 U.S.,” Thomas Rainey, senior vice president of U.S. Biosimilars at Teva, said. “This development allows us to serve patients battling gastrointestinal diseases as the U.S. 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 nine partnered products.”
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