FDA Approves Second Ustekinumab Biosimilar

The FDA has approved a new biosimilar, ustekinumab-aekn (Selarsdi), for the treatment of plaque psoriasis and psoriatic arthritis in adults and children aged 6 and older. This is the second ustekinumab biosimilar approved in the US and was developed by Alvotech in partnership with Teva Pharmaceuticals. Ustekinumab is a monoclonal antibody that targets interleukin-12 and IL-23. The approval was based on two clinical studies demonstrating its efficacy and safety. The biosimilar is expected to be on the market in the US after February 21, 2025. It is not approved for Crohn’s disease or ulcerative colitis.

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