Eye on Pharma: NeuClone to Start Phase 1 Trial of Ustekinumab Biosimilar

NeuClone announced yesterday that it will initiate a phase 1 clinical trial of its ustekinumab biosimilar, referencing Stelara, in the second half of 2019. Ustekinumab, a human interleukin-12 and -23 antagonist, is approved by the FDA to treat plaque psoriasis, psoriatic arthritis, and Crohn disease.

The proposed biosimilar, which NeuClone hopes to eventually market under the name NeuLara, was developed in partnership with the Serum Institute of India and will be tested in a multicenter, 3-arm, randomized, double-blind, single-dose phase 1 study to compare the pharmacokinetics and safety of the molecule versus US- and EU-licensed ustekinumab.

In May 2018, 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, and that the company was scaling up to facilitate the clinical study.

The proposed biosimilar is the second of NeuClone’s products to advance to a phase 1 trial; in October 2018, the company announced that it had begun a phase 1 trial of its proposed trastuzumab biosimilar referencing Herceptin.

NeuClone’s pipeline of biosimilars being developed with the Serum Institute also includes 4 products in late preclinical development: a denosumab product referencing Prolia, a palivizumab product referencing Synagis, an adalimumab product referencing Humira, and a pertuzumab product referencing Perjeta. The company is working on an additional 14 products that are not yet disclosed.

In addition to NeuClone, other biosimilar developers are advancing ustekinumab biosimilars. Fuji Pharma and Alvotech recently announced a deal to commercialize a biosimilar of the drug in Japan. Then, this week, Formycon announced that its own biosimilar, developed together with Aristo Pharma, had achieved “key milestones” in its development program, and a phase 1 clinical trial for Formycon’s product is planned for mid-2019.