Accord BioPharma, the US specialty division of Intas Pharmaceuticals, focused on the development of oncology, immunology, and critical care therapies, announced that the USFDA has approved IMULDOSA (ustekinumab-srlf), a biosimilar to STELARA (ustekinumab), for the treatment of chronic inflammatory conditions, including psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The FDA approved IMULDOSA for all indications of its reference medicine, STELARA. Accord anticipates a commercial launch of IMULDOSA in the first half of 2025.
USFDA approval of IMULDOSA was granted based on the data showing IMULDOSA similarity to its reference product STELARA in terms of pharmacokinetic characteristics, safety, tolerability, and efficacy, and that IMULDOSA adheres to current biosimilar guidance from the USFDA.
IMULDOSA was initially developed as DMB-3115 in 2013 by Dong-A Socio Holdings and Meiji Seika Pharma. In 2021, Intas Pharmaceuticals acquired exclusive commercialisation rights to DMB-3115 through a license agreement. As a global subsidiary of Intas Pharmaceuticals, Accord BioPharma will be responsible for US commercialisation of IMULDOSA.