Ustekinumab Biosimilar Selarsdi Gets FDA Approval

The Food and Drug Administration (FDA) has approved Selarsdi^™ (ustekinumab-aekn), a biosimilar to Stelara^® (ustekinumab).

Selarsdi is a human interleukin-12 and -23 antagonist indicated for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older.

The approval was based on a totality of evidence, including data from a phase 3 study (ClinicalTrials.gov Identifier: NCT04930042) that compared the efficacy and safety of Selarsdi to the reference product Stelara in patients with moderate to severe plaque psoriasis. Results showed the products were therapeutically equivalent, meeting the primary endpoint for psoriasis area and severity index percent improvement from baseline to week 12.

The approval was also supported by data from a phase 1 study (ClinicalTrials.gov Identifier: NCT04744363) that compared the pharmacokinetic, safety, tolerability and immunogenicity of Selarsdi administered as a single 45mg/0.5mL subcutaneous injection to Stelara. Findings showed bioequivalence between Selsardi and the reference product.

Selarsdi is supplied as 45mg/0.5mL and 90mg/mL single-dose prefilled syringes. The product is expected to be available in February 2025.