Biopharmaceutical company NeuClone has announced positive preclinical results of its biosimilar to Johnson & Johnson's Stelara, including 3-dimensional (3-D) structure confirmation through X-ray crystallography analysis.

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 that targets both interleukin-12 and -23 and is currently approved to treat various diseases including plaque psoriasis and Crohn's disease.

Dr Noelle Sunstrom, CEO of NeuClone, stated: "These results demonstrate our ability to create biosimilars using our Right from the Start® approach to biosimilarity, confirming each NeuClone product is indistinguishable from its originator at every stage of development. We develop crystals, functional cell-based assays and other tier 1 biosimilarity tests all in the same facility, allowing us to select the right candidate to go into the clinic."

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.

In comparison to reference monoclonal antibody products, biosimilar approval requires more extensive analytical data packages to demonstrate structural and functional characterisation of the biosimilar candidate. Analytical studies, such as X-ray crystallography, provide the foundations for determining biosimilarity.

In 2017, Stelara achieved global sales of USD 4.0 billion. EvaluatePharma has forecast global sales of Stelara® to reach USD 4.9 billion in 2022.

Stelara is marketed by Janssen, a wholly owned subsidiary of Johnson & Johnson.

NeuClone Pty. Ltd. is a private biopharmaceutical company 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.