Obtained product approval one year after applying to the U.S. FDA
Second domestic company to receive US approval after Samsung Bioepis
Dong-A ST receives FDA approval for the second time in 10 years
European approval goes smoothly… Application for product approval received last year
Dong-A ST announced on the 11th that Stelara biosimilar ‘Imuldosa (development name: DMB-3115, ingredient name: ustekinumab)’ has obtained product approval from the U.S. Food and Drug Administration (FDA). Accord Biopharma (Accord), a U.S. subsidiary of its partner company Intas, completed its application for product license (BLA) to the FDA in October last year, and product approval was issued on the 10th (local time) about a year later.
This is the second time that Dong-A ST has received product approval in the United States. In 2014, the antibiotic ‘Sivextro’ was the first drug approved by the FDA, and this time it was the second product approved in about 10 years. Through this, it is evaluated that it has proven its research and development (R&D) capabilities in the biopharmaceutical field, which has recently been strengthened.
Stellara is a treatment for autoimmune diseases developed by the American pharmaceutical company Janssen. It is a global blockbuster drug with global sales of approximately 14.7 trillion won. It is used to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. In particular, competition among domestic pharmaceutical and bio companies to develop biosimilars is intensifying ahead of the expiration of the original product’s material patent in major markets this year. Prior to Dong-A ST, Samsung Bioepis received product approval from the FDA, and Celltrion has also completed its application and is awaiting product approval.
In the case of Dong-A ST Emuldosa, Dong-A Socio Holdings and Meiji Seika Pharma began joint development in 2013. In July 2020, development and commercialization rights were transferred to Dong-A ST for efficient global development, and from then on, Dong-A ST and Meiji Seika Pharma performed joint development. In July 2021, a global technology export (licensing out) contract was signed with Intas, a multinational pharmaceutical company, and is currently in effect. Intas is pursuing global commercialization of Emuldosa through Accord in the United States. In Europe, the approval process is also going smoothly. Accord Healthcare, Insta’s European subsidiary, submitted an application for product approval to the European Medicines Agency (EMA) in June last year.
Park Jae-hong, President of Dong-A ST R&D, said, “This US FDA approval of Emuldosa is an achievement that has recognized Dong-A ST’s R&D capabilities and global competitiveness globally.” “We expect Dosa to successfully establish itself,” he said.
Meanwhile, Dong-A ST participated in ‘CPHI Worldwide 2024’, the world’s largest pharmaceutical and bio fair held in Milan, Italy from the 8th to the 10th (local time) and announced its own R&D capabilities and competitiveness. We also set up a joint booth with ST Pharm to explore overseas business opportunities. At this expo, Stelara biosimilar Imuldosa and GLP-1/glucagon dual agonist ‘DA-1726’, which is being developed as an obesity treatment, are said to have received a lot of attention.
Kim Min-beom, Donga.com reporter [email protected]
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