News List

NeuClone prepares for first human dose of Herceptin Biosimilar


NeuClone’s trastuzumab biosimilar is one of ten biosimilar products being developed in partnership with Serum Institute of India. 

By Team ABLE

Biopharmaceutical company NeuClone Ltdhas commenced first-in-human dosing of its Herceptin (trastuzumab) biosimilar candidate, in a Phase I clinical trial. The single-dose, randomized, three-arm, double-blind study is being conducted in Australia in over 100 healthy volunteers. Herceptin is marketed in the U.S. by Genentech, in Japan by Chugai Pharmaceutical and internationally by Roche. Herceptin is approved for HER2-overexpressing breast and gastric cancer.

The objective of the study is to demonstrate equivalent PK and safety of NeuClone’s trastuzumab biosimilar to Herceptin. NeuClone’s trastuzumab biosimilar is one of ten biosimilar products being developed in partnership with Serum Institute of India. 
“This major milestone offers significant validation of our biosimilar pipeline and partnership with Serum Institute,” stated Dr. Noelle Sunstrom, CEO and Founder of NeuClone. “Over the coming years we will progress multiple biosimilar products through clinical trials and toward registration.” 

Adar Poonawalla, CEO of Serum Institute of India stated, “This is only the beginning of our long-term biosimilar partnership with NeuClone. Following the trastuzumab biosimilar Phase I trial, the Stelara® (ustekinumab) biosimilar Phase I will be conducted in 2019. We are determined to replicate the success of our low-cost, large-scale vaccine business model with all ten biosimilars partnered with NeuClone.” 
The Phase I clinical trial is being conducted under the Australian Clinical Trial Notification (CTN) scheme. NeuClone Executive Chairman Dr. Russell Howard stated, “We recognize that our trastuzumab biosimilar is not a first to market candidate, however we are confident that in partnership with Serum Institute, we have the capabilities to enter the market with ultra-competitive prices, large scale supply, and the highest quality standards that adhere to global regulatory requirements.