Alvotech touts positive data on its proposed biosimilar to Stelara

Privately-held Icelandic biosimilars developer Alvotech Holdings has announced positive top-line results from a pharmacokinetic (PK) study for AVT04, its proposed biosimilar to Stelara (ustekinumab), marketed by US healthcare giant Johnson & Johnson’s (NYSE: JNJ) subsidiary Janssen Pharmaceutical for a variety of autoimmune diseases including ulcerative colitis and psoriasis.

The PK similarity study (AVT04-GL-101) utilized a single dose, three-arm, parallel design to compare pharmacokinetics, safety, tolerability, and immunogenicity of a single 45mg/0.5mL subcutaneous dose of AVT04, with US-licensed Stelara, as well as EU-approved Stelara. The study results demonstrated bioequivalence between AVT04 and the reference products.

Ustekinumab is a human IgG1κ monoclonal antibody that binds with specificity to the p40 protein subunit used by both the interleukin-12 and interleukin-23 cytokines. Stelara is prescribed to treat a variety of inflammatory conditions including psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.