Biosimilar Watch: FDA Accepts BLA for Proposed Stelara Biosimilar
The U.S. Food and Drug Administration (FDA) has accepted Accord BioPharma, Inc’s Biologics License Application (BLA) for DMB-3115, a proposed biosimilar to ustekinumab (Stelara, Johnson & Johnson). Ustekinumab is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The BLA submission for DMB-3115 is based on results from phase III multi-regional clinical trials in […]