The Meals and Drug Administration (FDA) has accredited Selarsdi
(ustekinumab-aekn), a biosimilar to Stelara® (ustekinumab).
Selarsdi is a human interleukin-12 and -23 antagonist indicated for the remedy of reasonable to extreme plaque psoriasis and for lively psoriatic arthritis in adults and pediatric sufferers 6 years and older.
The approval was based mostly on a totality of proof, together with knowledge from a part 3 examine (ClinicalTrials.gov Identifier: NCT04930042) that in contrast the efficacy and security of Selarsdi to the reference product Stelara in sufferers with reasonable to extreme plaque psoriasis. Outcomes confirmed the merchandise have been therapeutically equal, assembly the first endpoint for psoriasis space and severity index p.c enchancment from baseline to week 12.
The approval was additionally supported by knowledge from a part 1 examine (ClinicalTrials.gov Identifier: NCT04744363) that in contrast the pharmacokinetic, security, tolerability and immunogenicity of Selarsdi administered as a single 45 mg/0.5 mL subcutaneous injection to Stelara. Findings confirmed bioequivalence between Selsardi and the reference product.
Selarsdi is equipped as 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringes. The product is predicted to be accessible in February 2025.
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