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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.
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast Cancer Treatment
December 9th 2024The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Aflibercept Biosimilar MYL-1701P Provides Equivalence in DME Therapy
November 27th 2024The study findings demonstrate that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.
Ocrelizumab Biosimilar Shows Equivalent Efficacy as Multiple Sclerosis Treatment
November 26th 2024The phase 3 trial (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks.
