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.

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.