Teva Pharmaceutical Says Denosumab Biosimilars Get European Commission Marketing Approval

MT Newswires Live
Nov 25

Teva Pharmaceutical Industries (TEVA) subsidiary Teva Pharmaceuticals International said Tuesday that it received marketing authorizations from the European Commission for two denosumab biosimilar candidates.

The company said the authorizations were granted for Ponlimsi and Degevma, biosimilars to Amgen's (AMGN) Prolia and Xgeva, respectively. Ponlimsi is indicated for the treatment of osteoporosis in postmenopausal women and men at high risk of fractures, while Degevma is used to prevent bone complications in cancer patients, according to Teva.

Teva said it plans to launch the two products in key European markets in the coming months.

Their active substance, denosumab, is a human monoclonal IgG2 antibody that targets the protein essential for the formation, function and survival of cells responsible for bone resorption, Teva said.

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