Selarsdi Approved as Biosimilar to Stelara to Treat Plaque Psoriasis and Psoriatic Arthritis

The U.S. Food and Drug Administration (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. Ustekinumab is a human monoclonal antibody (mAb) that selectively targets the p40 protein, a component common to both interleukin (IL)-12 and IL-23 cytokines, which play crucial roles in treating immune-mediated diseases like psoriasis and psoriatic arthritis. Alvotech developed and produces Selarsdi using Sp2/0 cells and a continuous perfusion process, which are the same type of host cell line and process used in the production of Stelara. 

FDA approval of Selarsdi, referred to as AVT04 during development, was based on a totality of evidence, including analytical and clinical data. The clinical development program included data from 1) study AVT04-GL-301, a randomized, double blind, multicenter, 52-week study to demonstrate equivalent efficacy and to compare safety and immunogenicity between Selarsdi and the reference product Stelara in patients with moderate to severe chronic plaque-type psoriasis. The study was conducted in four countries in Europe and enrolled 581 patients. The primary efficacy endpoint was Psoriasis Area and Severity Index percent improvement from baseline to week 12; and 2) study AVT04-GL-101, a Phase I, randomized, double-blind, single-dose, parallel-group, three-arm study to compare the pharmacokinetic, safety, tolerability and immunogenicity profiles of Selarsdi, administered as a single 45mg/0.5mL subcutaneous injection with that of the U.S.-licensed Stelara, as well as EU-approved Stelara. The study was conducted in Australia and New Zealand and enrolled 294 healthy adult volunteers.