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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.
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.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
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.
Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo
November 7th 2024For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data
November 5th 2024Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.
