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Eye on Pharma: Meiji and Dong-A Begin Phase 1 Trial of Proposed Ustekinumab Biosimilar
Japan-based Meiji Seika Pharma and Republic of Korea-based Dong-A Socio Holdings announced this month that they have started a phase 1 clinical trial of DMB-3115, a proposed ustekinumab biosimilar referencing Stelara.
Japan-based Meiji Seika Pharma and Republic of Korea-based Dong-A Socio Holdings announced this month that they have started a phase 1 clinical trial of DMB-3115, a proposed ustekinumab biosimilar referencing Stelara.
The trial is a randomized, double-blind, 3-arm, single-dose study that will compare the pharmacokinetics, safety, and tolerability of the proposed biosimilar with both the EU-licensed and the US-licensed reference products in healthy volunteers. The study is taking place at a single site in Europe, and according to a statement by the companies, the first individual was dosed on December 13.
The proposed biosimilar is being manufactured by DM Bio Limited, headquartered in the Republic of Korea, a joint venture company that was established through a partnership agreement struck between Meiji and Dong-A in September 2011.
According to the agreement, the companies engage in joint research on biosimilars to expand their portfolios and undertake global clinical trials while reducing production costs.
The partnership is the latest to announce new initiatives on ustekinumab; Bio-Thera Solutions, a global biotechnology company based in China, has announced that Chinese regulators have given it clearance to start a phase 1 study of its ustekinumab product, BAT2206.
German drug maker Formycon announced in October that it has started a phase 1 clinical trial of its proposed biosimilar, FYB202.
Also in October, Australia’s NeuClone indicated that it has begun dosing participants with its proposed biosimilar, also in a phase 1 trial. The single-dose, double-blind, randomized, 3-arm, multicenter study is being conducted in Australia in more than 200 healthy volunteers.
Finally, Iceland-based Alvotech and Fuji Pharma have also indicated that they are in development with a ustekinumab product; in April, the companies announced a deal under which Alvotech will develop the product, and Fuji will sell the biosimilar in Japan.
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.
