BRIEF—China close to approving first Xgeva biosimilar

China is about to approve the country's first biosimilar of Amgen's Xgeva (denosumab), which is indicated for the prevention of skeletal-related events in people with bone metastases from solid tumors and in patients with multiple myeloma.

The biosimilar will be supplied by Qilu Pharmaceutical.

Xgeva was approved in China in 2019 and was commercialized under a licensing deal with BeiGene.

In 2020, it was covered by the national drug reimbursement list after an 80% price cut.

Xgeva currently is priced at 1,060 renminbi per vial (120ml) ($163.9).

If approved, the biosimilar, like denosumab which is also marketed as Prolia, will be used to treat three indications - giant cell tumor to bone, bone loss among women after menopause and tumor metastases to bone. Aside from Qilu, at least nine Chinese companies have their Xgeva biosimilars in different stages of clinical studies.