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Teva jumps on FDA approval for biosimilar
An FDA interchangeability approval for a biosimilar to ustekinumab could make a lower-cost alternative more available for people with Crohn’s disease or ulcerative colitis who use Stelara. It’s primarily a regulatory and market development rather than new clinical evidence about treatment effects.
Adult patients on or considering ustekinumab (Stelara), caregivers, clinicians who prescribe biologics, and people following biosimilar access and drug-cost issues.
What To Know
The FDA has approved Selarsdi, a biosimilar to Stelara (ustekinumab), and Teva (with partner Alvotech) has launched it and received an interchangeability designation covering Stelara’s approved indications, including Crohn’s disease and ulcerative colitis.
This is a regulatory and commercial update — an FDA interchangeability ruling means the biosimilar can be substituted for the reference biologic at the pharmacy level in the U.S., and the article highlights Teva’s launch and market implications rather than clinical data or new trial results.
For patients: Interchangeability may affect availability, insurance coverage, and potentially cost or prescribing choices in the future, but the article does not report any new efficacy or safety data specific to Selarsdi.
For clinicians/researchers: The news is relevant for formulary decisions and market competition; clinicians should consult product labeling, FDA documents, and payor policies for details on approved indications and substitution rules.
This article is a business/news report about FDA approval and Teva’s commercial launch; it does not present clinical trial results or safety data. Substitution practices, insurance coverage, and local pharmacy policies will determine how and when patients might be switched. For clinical details, refer to the FDA approval documents and product labeling.
