Dong-A ST StellaRA Biosimilar 'Imuldosa', EU Approval Imminent Following US

Dong-A ST (Dong-A ST) is expected to soon receive approval in Europe following the United States for Imuldoza (development name DMB-3115), a biosimilar of Stelara.

Exterior view of Dong-A ST headquarters building
[Photo by Dong-A ST]

On the 21st, Dong-A ST announced that Accord Healthcare, a subsidiary of Intas, an India-based multinational pharmaceutical company and its partner, received a recommendation for marketing authorization approval for Imuldoza from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) on the 18th (local time). This comes about 1 year and 4 months after the marketing authorization application was completed with the EMA in June last year.

This approval recommendation is not the final approval. The European drug approval process proceeds by CHMP scientifically evaluating the quality, safety, and efficacy of the drug and then discussing whether to approve it, providing an opinion to the EMA, after which the European Commission (EC) makes the final approval decision. However, when a recommendation for approval is received, the EC usually grants final approval within two months at the latest. Imuldoza was previously approved by the U.S. Food and Drug Administration (FDA) on the 10th (local time).

Imuldoza is a drug developed as a biosimilar of Stelara, an autoimmune disease treatment developed by Johnson & Johnson (J&J) Innovative Medicine (formerly Janssen). It treats inflammatory diseases such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis by inhibiting inflammatory cytokines interleukin (IL)-12 and IL-23. Since the substance patent expired in September last year, global competition for biosimilar development has intensified. According to IQVIA, a pharmaceutical market research firm, the global market size of ustekinumab, the main ingredient of Stelara, reached $20.323 billion (approximately 28 trillion KRW) last year.

The Dong-A Socio Group has been developing Imuldoza together with Japan's Meiji Seika Pharma since 2013. In July 2020, to efficiently carry out the global project, the rights within the group were transferred to Dong-A ST, and since then, Dong-A ST and Meiji Seika Pharma have jointly developed the drug. In July 2021, a global license-out agreement for Imuldoza was signed with Intas. Intas plans to commercialize Imuldoza worldwide through its affiliates, including Accord Biopharma in the United States and Accord Healthcare in Europe, the United Kingdom, and Canada.

A Dong-A ST official said, “With Imuldoza receiving a recommendation for marketing authorization approval from CHMP following FDA approval, Dong-A ST’s research and development (R&D) capabilities have been proven once again,” adding, “We hope Imuldoza will be successfully launched in the U.S. and European markets and become a better treatment option for many patients.”

This content was produced with the assistance of AI translation services.