FDA approves Selarsdi as Stelara biosimilar for psoriasis, psoriatic arthritis

Key takeaways:

• Selarsdi is approved for the treatment of plaque psoriasis, psoriatic arthritis in adults, patients aged 6 years and older.
• The approval is based on two clinical trials.

The FDA has approved Selarsdi as a biosimilar to Stelara for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis, Teva Pharmaceuticals and Alvotech announced in a press release.

Selarsdi (ustekinumab-aekn) injection is now approved for subcutaneous use as an interchangeable biosimilar to Stelara (ustekinumab, Janssen) for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and patients aged at least 6 years.

According to the release, Stelara sales were nearly $7 billion in 2023. With this new approval, the availability of Selarsdi as a Stelara biosimilar will provide cost-saving opportunities and additional treatment options for patients.

“Bringing Selarsdi to market in the U.S. early next year presents a significant opportunity to improve patient access to a vital biologic in inflammatory disease and contribute to the reduction of inflationary pressure in health care costs,” Robert Wessman, chairman and CEO of Alvotech, said in the press release.

The approval of Selarsdi, referred to as AVT04 during development, was based on two trials, the first being a randomized, double-blind, multicenter, 52-week study that demonstrated Selarsdi’s equivalent efficacy and safety to Stelara in 581 patients with moderate to severe chronic plaque psoriasis.

The second was a phase 1, randomized, double-blind, single-dose, parallel-group, 3-arm study to compare Selarsdi’s pharmacokinetic profile, administered as a single 45 mg/0.5 mL subcutaneous injection vs. Stelara in 294 healthy adults.

According to the strategic partnership agreement between Teva and Alvotech, Teva will be responsible for the exclusive commercialization of Selarsdi in the U.S.