BioPharma Dive April 17, 2024
Kristin Jensen

The companies plan to launch their copycat version of the blockbuster drug early next year, per a legal settlement with J&J.

Dive Brief:

  • Alvotech and Teva on Tuesday won Food and Drug Administration approval for Selarsdi, the second biosimilar poised to challenge Johnson & Johnson’s blockbuster psoriasis drug, Stelara.
  • The FDA cleared Selarsdi for treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children who are at least 6 years old. The companies said they expect to begin selling the medicine on or after Feb. 21, 2025, a delayed introduction due to a legal settlement with J&J.
  • The two companies are likely to enter the market after Amgen, which won approval for an interchangeable...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma / Biotech
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