Novartis biosimilar matches Amgen's bone disorder drug Prolia, meeting trial's goal
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Novartis (NYSE:NVS) said its potential biosimilar of Amgen's (NASDAQ:AMGN) bone disorder drug Prolia (denosumab) was as good as the reference product.
In the phase 1/3 trial, dubbed ROSALIA, 527 postmenopausal women with osteoporosis received either biosimilar denosumab or the reference medicine, for up to 78 weeks, Novartis generic/biosimilar unit Sandoz said in a Sept. 19 press release.

The study met its main goal, showing that the proposed biosimilar matched Prolia in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in postmenopausal women with osteoporosis.
Prolia is used to treat several conditions, including osteoporosis in postmenopausal women, in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer which has spread to the bone, and giant cell tumor of the bone. About 500M million men and women worldwide may be affected by osteoporosis, which causes ~8.9M fractures annually, Sandoz noted.