Celltrion announced last Friday that it will begin Phase I clinical trials of its Prolia (denosumab) biosimilar (CT-P41) in September. Prolia, marketed and sold by Amgen, is a treatment for glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture. Celltrion has said it plans to finish Phase 3 clinical trials by the end of the first quarter of 2025.
Celltrion also announced last week that Celltrion Healthcare Co. (Celltrion’s marketing and distribution arm) has signed an agreement with Intract Pharma to develop the first tablet product of CT-P13, an infliximab biosimilar used to treat a number of autoimmune diseases. It will be the first tablet-type treatment on the market with infliximab as the main ingredient. This includes Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behçet’s disease.