Intas Pharmaceuticals Ltd, an Indian pharmaceutical company and partner of China’s Shanghai Henlius Biotech Inc. (HKG: 2696), has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its ustekinumab-srlf. This biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara (ustekinumab) will be marketed under the trade name Imuldosa in the US. The product is now approved for use in treating chronic inflammatory conditions such as psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
Stelara, the world’s first all-human “dual-targeted” inhibitor of interleukin 12 (IL-12) and interleukin 23 (IL-23), has received five indication approvals in the US from J&J, covering a range of conditions including ulcerative colitis, Crohn’s disease, active psoriatic arthritis, and psoriasis in addition to plaque psoriasis. Stelara was first approved in China in 2017 and reported sales of USD 10.858 billion in 2023, highlighting its significance in the treatment of autoimmune diseases.- Flcube.com
