US-US FDA has Zulassung für IMULDOSA (Ustekinumab-srlf) von Dong-A ST

In October 2023, a Organic Lizenzantrag (BLA) from Dong-A ST for Imuldosa organization was generated by the US Food and Drug Administration

Dong-A ST (President/CEO Jae-Hun Jung, KRX: 170900) launched on October 11 with Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar with referenz for Stelara®, the Zulassung of the American-American Erhalten hat of the Food and Drug Administration (FDA).

If we found the FDA zugelassene biosimilar with Sivextro® (Tedizolidphosphat) in the year 2014, the F&E compositions were established.

The investigation follows the Annahme of Accord BioPharma, a hundertprozentigen Tochtergesellschaft of Intas Pharmaceuticals, in October 2023 eingereichten Zulassungsantrags (BLA) by the FDA.

It is a biosimilar of Stelara, a Blockbuster drug, from Janssen Biotech Inc. for the treatment of patients with autoimmune disease with plaque psoriasis, psoriasis arthritis, Crohn’s disease and ulcerative colitis entwickelt. It is one of the largest biopharmaceutical products and produces 10.86 billion US dollars (IQVIA accumulative turnover in 2023).

Dong-A Socio Holdings and Meiji Seika Pharma started in 2013 with the establishment of Imuldosa and the rights for F&E and the sale in July 2020 by Dong-A Socio Holdings on Dong-A ST, an efficient project management for their gewährleisten. In July 2021, Dong-A ST and Meiji Seika Pharma is a global Lizenzvereinbarung with Intas Pharmaceuticals, the Biosimilar with its global activities with Accord BioPharma from the USA and Accord Healthcare from the EU, Great Britain and Canada on the market.

Darüber, Accord Healthcare in June 2023 contributed to the market (MAA) at the European Arzneimittelagentur (EMA) which was launched in July 2023.

Dr. Jae-Hong Park, Head of R&D at Dong-A ST, commented: “This FDA approval said that the world wide recognition of F&E excellence and the global regulatory environment of Dong-A ST. US is the largest pharmaceutical market in the world, where we see more and more innovative medicines, a global prize that we will increasingly appreciate.”