Celltrion files BLA for interchangeable Prolia® (Denosumab) Biosimilar with the FDA

The Korea Biomedical Review reported that Celltrion has submitted an application for marketing authorisation to the FDA for CT-P41, its biosimilar to Amgen’s Prolia® (denosumab) for the treatment of osteoporosis and related diseases.  The KBR reported that Celltrion has confirmed CT-P41’s equivalence and similarity in a phase III trial, and is seeking approval as an interchangeable biosimilar.