BioPharma Dive April 17, 2024
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...