Celltrion announced today that it has filed an application for the marketing authorization of its, ‘CT-P41,’ to the US Food and Drug Administration (FDA). CT-P41 is a biosimilar of ‘Prolia,’ a treatment for osteoporosis.

Based on the results of a global Phase III clinical trial on CT-P41, Celltrion filed for marketing authorization of its substance for all of Prolia’s indications, including osteoporosis, bone loss, prevention of skeletal complications from multiple myeloma or solid cancer bone metastases, and giant cell tumor of bone.

Prolia is a biological osteoporosis treatment that targets the RANKL protein essential for the formation, activation, and survival of osteoclasts that