Tagged as: NeuClone

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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NeuClone Announces Active Development of Biosimilars Referencing OPDIVO and KEYTRUDA

On Sept. 1, 2020, NeuClone Pharmaceuticals announced that they are developing biosimilar candidates referencing OPDIVO and KEYTRUDA. According to NeuClone, the two biosimilar candidates “are in the advanced states of pre-clinical development.”  This brings the number of NeuClone’s biosimilar pipeline to 8 announced products with another 12 in development that…

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New Phase I Clinical Trials for Two Proposed Ustekinumab Biosimilars

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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NeuClone Commences Human Dosing of Biosimilar Trastuzumab in Phase I Clinical Trial

Last week, NeuClone Ltd. announced it commenced its Phase I clinical trial for its biosimilar Herceptin® (trastuzumab).  According to NeuClone, the Phase I trial is a single-dose, randomized, three-arm double blind study of over 100 healthy volunteers, conducted under the Australian Clinical Trial Notification (CTN) scheme.  According to NeuClone, “[t]his…

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