FDA Approves Dong-A ST’s IMULDOSA™ Biosimilar to STELARA®

Dong-A ST announced on October 11 that the U.S. Food and Drug Administration has approved Imuldosa™ (ustekinumab-srlf/DMB-3115), a biosimilar to Stelara®. This marks the company's second FDA-approved biosimilar, following the approval of Sivextro® (tedizolid phosphate) in 2014, underscoring its robust research and development capabilities.

The biologics license application (BLA) for Imuldosa was submitted by Accord BioPharma, a fully owned subsidiary of Intas Pharmaceuticals, in October 2023. Imuldosa is modeled after Stelara, a widely used drug developed by Janssen Biotech Inc. Stelara is prescribed for treating patients with autoimmune diseases such as plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. In 2023, Stelara generated global revenues of $10.86 billion, making it one of the top-grossing biopharmaceuticals.

The joint development of Imuldosa commenced between Dong-A Socio Holdings and Meiji Seika Pharma in 2013. To streamline project management, the rights for research, development, and commercialization were transferred from Dong-A Socio Holdings to Dong-A ST in July 2020. A year later, in July 2021, Dong-A ST and Meiji Seika Pharma entered into a global license agreement with Intas Pharmaceuticals. Intas, through its global subsidiaries such as Accord BioPharma in the U.S. and Accord Healthcare in the EU, UK, and Canada, is set to commercialize the biosimilar.

Additionally, Accord Healthcare submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) in June 2023, which was accepted in July 2023. This step signifies a potential expansion of Imuldosa into the European market.

Dr. Jae-Hong Park, Head of R&D at Dong-A ST, remarked on the significance of this approval, stating that it symbolizes global recognition of Dong-A ST’s research and development excellence and competitiveness. He expressed confidence in the successful launch of Imuldosa in the U.S., which is the largest pharmaceutical market in the world. Dr. Park emphasized the company’s commitment to developing innovative medicines to bolster their global footprint further.