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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 reference product under state rules, affecting treatment supply and insurance coverage.
Adult patients and caregivers using ustekinumab (Stelara) for Crohn’s disease or ulcerative colitis, clinicians who prescribe biologics, pharmacists, and patient advocates focused on medication access and affordability.
What To Know
FDA approval news: The FDA has granted Selarsdi (ustekinumab-aekn), a biosimilar to Stelara (ustekinumab), an interchangeability designation for multiple indications including Crohn disease and ulcerative colitis. The approval covers both subcutaneous prefilled syringe strengths (45 mg/0.5 mL and 90 mg/mL) and an intravenous 130 mg/26 mL single-dose vial.
The announcement is presented as a regulatory and commercial milestone by Teva and Alvotech. What this means practically: Interchangeability means pharmacists in the U.S. may substitute Selarsdi for Stelara without prescriber intervention where state pharmacy laws allow, which the companies say could increase access and lower costs.
The article quotes company statements and places the news in the context of other Stelara biosimilars and IBD prevalence data, but it does not provide clinical guidance, switching protocols, or new safety/effectiveness data beyond the regulatory decision. If you are on ustekinumab: This is news to discuss with your prescribing clinician or pharmacist.
The article reports regulatory approval and manufacturer commentary; it does not replace clinical advice about switching, insurance coverage, or monitoring during a change in product.
This is a regulatory approval and company announcement; it does not present new clinical trial outcomes or detailed switching/safety data. State pharmacy substitution laws determine how interchangeability is implemented in practice, and insurers decide coverage and formulary placement. Talk with your provider or pharmacist before making any treatment changes.
