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Dong-A Socio Holdings starts the phase I clinical study of the biosimilar Stelara in Europe with…

On December 16, Dong-A Socio Holdings (President Han Jong-hyun) announced that the company and Meiji Seika Pharma (President Kobayashi Daikichiro) had launched the phase I clinical study of DMB-3115, a biosimilar of Stelara, in Europe.

Since 2013, Dong-A Socio Holdings and Meiji Seika Pharma have been working on the joint development of DMB-3115, for which the pre-clinical study in Korea was completed in 2018. The phase I clinical study in Europe will be conducted on 300 healthy adults using clinical samples produced by DM Bio.

Stelara (Ustekinumab) is a biopharmaceutical developed by Janssen, USA, which is used as a treatment for plaque psoriasis in both pediatric patients over the age of 12 and adult patients, psoriatic arthritis in adult patients, and Crohn’s disease in adult patients.

This year, the range of Stelara’s indications was expanded to the treatment of ulcerative colitis in adult patients, while global sales of the drug reached approximately USD 5.1 billion (KRW 5.99 trillion).

In September 2011, Dong-A Socio Holdings (formerly Dong-A Pharm before split-off) signed a strategic alliance with Meiji Seika Pharma for the joint development of biosimilars, while DM Bio, a joint venture, is responsible for producing clinical samples and products after commercialization.

DM Bio has the capacity to produce up to 8,000L of cGMP antibody biopharmaceuticals. The company not only produces biosimilars jointly developed by the two companies, but also operates a CDMO business that provides services such as contract manufacturing and process development.

An executive of Dong-A Socio Holdings said, “We have successfully developed the pre-clinical phase of DMB-3115 by exploiting our wealth of experience in the development and commercialization of first-generation biopharmaceuticals such as Eporon, a growth hormone and renal anemia treatment, Leucostim, a neutropenia treatment, and Gonadopin, an infertility treatment. Starting with the phase I clinical studies in Europe, we will work closely with Meiji Seika Pharma to launch DMB-3115 in the global market.”