Policy & Regulation
NeuClone Uses X-ray Crystallography to Confirm Stelara (ustekinumab) Biosimilar Candidate
15 May 2018 - - Sydney, Australia-based biopharmaceutical company NeuClone has released positive preclinical results of its biosimilar to Johnson and Johnson's Stelara, including 3-dimensional structure confirmation through X-ray crystallography analysis, the company said.
X-ray crystallography analysis confirms identity and equal structural integrity of NeuClone's biosimilar and the reference product Stelara, in both primary amino acid sequence and 3-D folding (structure).
Stelara is a monoclonal antibody marketed by Janssen, a wholly owned subsidiary of Johnson and Johnson, that targets both interleukin-12 and -23 and is currently approved to treat various diseases including plaque psoriasis and Crohn's disease.
NeuClone's Stelara biosimilar is co-developed with Serum Institute of India and is currently in process scale up to support planned Phase I clinical trials in 2019. This will be the company's second product to enter clinical studies in Australia following its first product, a biosimilar of Roche / Genentech's Herceptin.
Privately held NeuClone is focused exclusively on developing a pipeline of biosimilar products. Five biosimilar products have been disclosed in NeuClone's pipeline that reference Herceptin, Stelara, Humira, Synagis and Prolia/XGEVA.
NeuClone develops biosimilar products using its proprietary NeuMAX platform that facilitates low-cost manufacture of biologics, whilst enabling the highest product quality.
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