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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.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
