FDA Approves Selarsdi, a Biosimilar to Stelara
The FDA has approved Selarsdi (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older.
- Introduced through a strategic partnership between Teva Pharmaceutical Industries Ltd. and Alvotech, for the exclusive commercialization of five of Alvotech’s biosimilar product candidates, Teva will be responsible for the exclusive commercialization of Selarsdi in the United States.
- Sales of Stelara in the U.S. were nearly $7 billion in 2023. The availability of a Stelara biosimilar will create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients.
- In the U.S., plaque psoriasis is the most common form of psoriasis while psoriatic arthritis accounts for approximately six percent of all cases of juvenile arthritis.
Source: Teva Pharmaceutical Industries Ltd.
