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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.
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.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
