Tagged as: Stelara

Positive Results From Ustekinumab Biosimilar Phase I Trial and Infliximab Biosimilar Switching Studies

On October 20, 2020, NeuClone announced that it successfully completed its Phase I clinical trial of NeuLara, its proposed biosimilar of Stelara (ustekinumab).  According to Neuclone, the Phase I clinical trial demonstrated similar clinical pharmacokinetics, and safety, immunogenicity and tolerability profiles of NeuLara compared to US- and EU-sourced Stelara.  NeuLara…

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New Phase I Clinical Trials for Two Proposed Ustekinumab Biosimilars

gloved hand withdraws drug solution with syringe

Over the last two weeks, NeuClone and Formycon announced updates regarding their respective ustekinumab biosimilars (reference product, Stelara). On October 17, 2019, NeuClone announced that it has launched a Phase I clinical trial of its ustekinumab product, NeuLara.  NeuClone stated that the Phase I clinical trial is a “single-dose, double-blind, randomised,…

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Alvotech and Fuji Pharma Partner to Commercialize Alvotech’s Ustekinumab Biosimilar

Earlier this month, Alvotech announced that it entered into an agreement with Fuji Pharma, giving Fuji Pharma the exclusive right to commercialize its biosimilar of Stelara® (ustekinumab) in Japan.  The press release states that, in exchange for developing and providing Fuji Pharma with a commercial supply of its ustekinumab biosimilar, Alvotech will…

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