Sandoz wins FDA approval for first two biosimilars for Amgen’s blockbuster bone drug

San­doz said Tues­day that the FDA signed off on two of its biosim­i­lars to Am­gen’s bone drug deno­sum­ab. But as with oth­er high-pro­file biosim­i­lar ap­provals, it’s un­clear when ei­ther of the two new prod­ucts might launch and how low prices may fall.

The ap­provals are the first sign that Am­gen’s block­busters Pro­lia, for os­teo­poro­sis in women af­ter menopause, and Xge­va, which is in­di­cat­ed to treat bone can­cer and bone prob­lems in can­cer pa­tients, are go­ing to lose mar­ket share. Pro­lia and Xge­va, the dual brand names for deno­sum­ab, col­lec­tive­ly hauled in more than $6 bil­lion last year for Cal­i­for­nia-based Am­gen.

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