Posted by Michael Wonder on 01 Sep 2023
Celltrion applies for Australian approval for Stelara biosimilar
31 August 2023 - Celltrion said it has completed a marketing authorisation application for CT-P43, a biosimilar referencing Stelara (ustekinumab) that treats autoimmune diseases, to Australia’s TGA on Thursday (local time).
Celltrion filed a marketing authorisation application in Australia for CT-P43 for the full range of indications covered by the original Stelara, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
