Alvotech has reported positive results from a key study for its AVT04 proposed biosimilar to Stelara (ustekinumab), with pharmacokinetic similarity data demonstrating equivalence to the reference brand.
The single-dose, three-arm, parallel-design PK similarity study was conducted in Australia and New Zealand with 294 healthy adult volunteers. It compared pharmacokinetics, safety, tolerability, and immunogenicity of a single 45mg/0.5ml subcutaneous dose of AVT04 with US-licensed as well as EU-approved versions of Stelara
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