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Cure8 news brief
Why This Matters
A new ustekinumab biosimilar (SELARSDI) is now available in the U.S. for Crohn’s disease and ulcerative colitis, which may expand treatment options and affect access or cost for patients on biologic therapy.
Who Should Pay Attention
Adults with Crohn’s disease or ulcerative colitis considering or currently on ustekinumab/Stelara, clinicians who prescribe biologics, and patients interested in biosimilar access and cost.
Study Snapshot
Story typeBusiness news
Evidence typeRegulatory update
Source depthFull source text
What To Know
The FDA-approved biosimilar SELARSDI (ustekinumab-aekn) is now available in the U.S. as an alternative to the reference biologic Stelara (ustekinumab).
The press release notes SELARSDI has a provisional determination of interchangeability with Stelara once exclusivity for the first interchangeable biosimilar expires, and lists approved presentations including subcutaneous prefilled syringes/vials and an intravenous vial presentation.
SELARSDI is approved for the same indications as Stelara, including moderately to severely active Crohn’s disease and ulcerative colitis in adults, and certain psoriasis and psoriatic arthritis indications (including pediatrics 6 years and older).
The announcement frames the launch as increasing treatment options and potential cost savings through biosimilars under the Teva–Alvotech partnership. This is a commercial/regulatory availability announcement rather than a clinical trial report.
It does not provide new efficacy or safety data beyond the FDA approval and listed prescribing indications; consult prescribing information and a clinician for individual treatment questions.
Keep In Mind
This is a company press release announcing U.S. market availability and a provisional FDA interchangeability determination; it does not present new clinical trial results. Interchangeability details depend on FDA exclusivity timelines noted in the release. For clinical decisions, refer to official prescribing information and discuss with your healthcare provider.
Source Details
Review the original publication for the complete reporting, methods, and context.
Regulatory update
Article type assigned from Cure8 classification; confirm details in the original source.
Publicationmarkets.businessinsider.com
Indexed viaBing News
Source typeBusiness news
PublishedFeb 21, 2025, 3:21 AM
Content availableFull source text
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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