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Tuesday, April 16, 2024

Alvotech, Teva Announce: FDA OKs SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara

 

  • 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 U.S. on or after February 21, 2025, following a settlement agreement with Johnson & Johnson, the manufacturer of Stelara

  • SELARSDI was developed and is manufactured by Alvotech using murine cell (Sp2/0) and a continuous perfusion process, which are the same type of cells and process used for the production of Stelara

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