Datapoint: Sandoz Reaches Agreement With Amgen to Launch Prolia, Xgeva Biosimilars

Sandoz reached an agreement with Amgen Inc. resolving all patent litigation related to denosumab, Sandoz revealed April 30. The FDA approved Sandoz’s Jubbonti (denosumab-bbdz) and Wyost (denosumab-bbdz) on March 5 as biosimilar to and interchangeable with Amgen’s Prolia (denosumab) and Xgeva (denosumab) for all of their indications. They are the first FDA-approved denosumab biosimilars. The agreement will allow the agents to launch on May 31, 2025, or earlier “under certain circumstances if customary acceleration provisions are triggered.” Prolia was first approved in 2010 for the treatment of osteoporosis in postmenopausal women at high risk of bone fracture. For this indication, the injectable currently holds covered or better status for 94% of all insured lives under the medical benefit, and 69% of lives under the pharmacy benefit.

SOURCE: MMIT Analytics, as of 5/13/24

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