NeuClone Announces Positive Results of Analytical Studies for Ustekinumab Biosimilar

The Center for Biosimilars Staff

Today, Australian drug developer NeuClone announced positive preclinical results of its proposed ustekinumab biosimilar referencing Stelara. Ustekinumab is a monoclonal antibody that targets interleukin-12 and -23, and the reference product is approved to treat plaque psoriasis, psoriatic arthritis, and Crohn disease.

Today, Australian drug developer NeuClone announced positive preclinical results of its proposed ustekinumab biosimilar referencing Stelara. Ustekinumab is a monoclonal antibody that targets interleukin-12 and -23, and the reference product is approved to treat plaque psoriasis, psoriatic arthritis, and Crohn disease (CD).

The company announced that it had confirmed the similarity of its molecule to that of the reference product using an X-ray crystallography analysis of both primary amino acid sequence and 3-dimensional folding structure.

NeuClone is developing the proposed product with its partner, Serum Institute of India, and is scaling up to support a planned phase 1 trial of the biosimilar in 2019. Other biosimilars in the drug developer’s pipeline include trastuzumab (referencing Herceptin), which is slated to enter a phase 1 trial in 2018, and preclinical candidates for denosumab (referencing Prolia), palivizumab (referencing Synagis), and adalimumab (referencing Humira), and an additional 5 undisclosed products.

While the market for psoriasis treatments is heating up, with biologic competitors such as guselkumab (Tremfya) and ixekizumab (Taltz) vying for market share, Stelara’s most recently approved indication for the treatment of CD—which the FDA granted in September 2016 on the basis of positive data from 3 pivotal phase 3 studies—helps to buoy sales of the drug for Johnson & Johnson. In the treatment landscape for CD, the option to use an interleukin blocker provides an important alternative for patients who have not had an adequate response to treatment with an anti—tumor necrosis factor therapy.

On the strength of Stelara’s sales in all 3 indications, in its third-quarter 2017 earnings update, Johnson & Johnson, maker of the reference Stelara, reported $800 million in US sales for the quarter, up 42% from the same period in 2016, and $324 million in international sales, up 28.1%.

Another company that has disclosed its efforts to develop a biosimilar of the ustekinumab molecule is German drug maker Formycon, which, together with its partner Aristo Pharma, is in preclinical development with its candidate, FYB202.