Blog Big Molecule Watch May 18, 2022

Alvotech Announces Positive Results from a Pharmacokinetic Similarity Study for Ustekinumab Biosimilar

On May 16, 2022, Alvotech Holdings S.A. (“Alvotech”) announced positive top-line results from a pharmacokinetic (PK) study for AVT04, Alvotech’s proposed biosimilar to STELARA® (ustekinumab).  Alvotech notes that the study used “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 U.S.-licensed STELARA®, as well as EU-approved STELARA®” and that the study results “demonstrated bioequivalence between AVT04 and the reference products.”  STELARA® is prescribed to treat a variety of inflammatory conditions, including psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.  Joseph McCellan, Alvotech’s Chief Scientific Officer, stated, “We are pleased with the successful outcome of the AVT04 PK similarity study and the continued progress of our overall pipeline.  We expect the results from our confirmatory efficacy and safety study for AVT04 before the end of the 2nd quarter.”

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