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 pathway offers a streamlined approach and data output is supported by global regulatory agencies such as the EMA and U.S. FDA.”

NeuClone also reports that it has partnered with Serum Institute of India to develop ten biosimilars.  According to the press release, NeuClone representatives will attend the upcoming November 2018 BIO-Europe conference and “look forward to meeting potential commercialisation partners.”