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Our research partner Alvotech has announced positive results from a Pharmacokinetic Similarity Study for AVT04, a Proposed Biosimilar to Stelara® conducted at NZCR research facilities.
The PK similarity study (AVT04-GL-101) utilised a single dose, 3-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 IgG1k 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.
NZCR is delighted to be actively involved with Alovotech’s development portfolio including AVT02, a biosimilar to Humira® (adalimumab)
New Zealand Clinical Research (NZCR) provides state of the art research facilities and the expertise to conduct complex early phase clinical research in healthy participant and patient populations.