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FDA approves Selarsdi injection as interchangeable with Stelara

Teva Pharmaceuticals and Alvotech have announced that the US Food and Drug Administration (FDA) has approved the Selarsdi (ustekinumab-aekn) injection as interchangeable with reference biologic ...
Monthly Prescribing Reference

Pyzchiva, a Biosimilar to Stelara, Gets FDA Approval

The approval was based on a totality of evidence, including data from a phase 3 study (ClinicalTrials.gov Identifier: NCT04967508) that compared the efficacy and safety of Pyzchiva to the reference ...
Nasdaq

Bio-Thera Solutions and Hikma Pharmaceuticals announce FDA approval of STARJEMZA® (ustekinumab-hmny) Injection, a biosimilar referencing STELARA® (ustekinumab) Injection

GUANGZHOU, China and LONDON, May 27, 2025 /PRNewswire/ -- Bio-Thera Solutions, Ltd (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of biosimilars and innovative assets ...
Business Wire

Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab)

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva SELARSDI is expected to be marketed in the ...
MM&M

In all-star immuno-matchup, AbbVie’s Skyrizi bests J&J’s Stelara

Funding a head-to-head study against a rival is risky. When that rival’s initials are “J” and “J,” it’s an even riskier bet. However, it’s just the sort of endeavor that appears to have paid off for ...