benzinga.com
Cure8 news brief
Why This Matters
An interchangeable FDA approval can increase availability and potentially reduce costs for biologic treatments used in Crohn’s disease and ulcerative colitis. This may affect medication access, pharmacy substitution, and insurance coverage for patients on ustekinumab or similar biologics.
Who Should Pay Attention
Patients with Crohn’s disease or ulcerative colitis on or considering ustekinumab; caregivers; clinicians, pharmacists, and health systems managing biologic therapies; researchers and industry watchers tracking biosimilars.
Study Snapshot
Story typeBusiness news
Evidence typeRegulatory update
Source depthFull source text
What To Know
Selarsdi is an FDA-approved interchangeable biosimilar to Stelara; interchangeable designation means pharmacists can substitute it for the reference product where allowed by law. The article lists the approved presentations and says Selarsdi is approved for indications that include Crohn’s disease and ulcerative colitis.
Teva and Alvotech’s partnership has produced multiple biosimilar approvals and additional candidates in review, which is the main reason the company’s stock moved. No clinical recommendations or comparative effectiveness data are provided in the article.
If you are on ustekinumab or another biologic, any switch to a biosimilar would be handled by your care team and pharmacy; this article reports a regulatory/market development rather than clinical trial outcomes.
Keep In Mind
Interchangeability and market launch are regulatory and commercial milestones; they do not automatically change individual treatment decisions. Coverage, pharmacy substitution policies, and clinical monitoring after any switch are determined by prescribers, payers, and pharmacies.
The article focuses on Teva’s business strategy and FDA approvals rather than clinical efficacy or safety comparisons.
Source Details
Review the original publication for the complete reporting, methods, and context.
Publicationbenzinga.com
Indexed viaBing News
Source typeBusiness news
PublishedMay 5, 2025, 8:43 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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Teva and Alvotech Announce SELARSDI™ (ustekinumab-aekn) Injection Now Available in the U.S.
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.
FDA Approves Interchangeability Designation for Teva and Alvotech’s Stelara Biosimilar Selarsdi for Multiple Indications
An interchangeable biosimilar to ustekinumab could expand access and lower costs for people with Crohn’s disease and ulcerative colitis who use Stelara. Pharmacists may be able to substitute the biosimilar for the...