Ustekinumab Biosimilar Receives Interchangeability Approval
Conexiant
May 5, 2025
Ustekinumab-aekn (Selarsdi) is approved for all indications of the reference product, including psoriasis and Crohn’s disease.
The FDA approved the ustekinumab biosimilar as interchangeable with the reference biologic ustekinumab (Stelara).
The biosimilar is produced using Sp2/0 cells and a continuous perfusion process, similar to the reference biologic.
The safety profile of the ustekinumab biosimilar is consistent with the reference product, including risks for serious infections.
The ustekinumab biosimilar is contraindicated in patients with known hypersensitivity to ustekinumab or its excipients.
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