News Briefs: FDA Accepted Application for Sanofi’s Biosimilar Denosumab
The FDA accepted its first application for a biosimilar denosumab, Sandoz disclosed on Feb. 6. The Amgen Inc. reference drug is available as both Prolia and Xgeva. According to AmerisourceBergen’s Feb. 6 U.S. Biosimilar Report, nine companies have denosumab biosimilars in clinicals trials, with five of those in Phase III trials. Prolia and Xgeva are approved for multiple conditions, including for the treatment of postmenopausal women with osteoporosis at high risk for fracture and for the prevention of skeletal-related events in people with multiple myeloma and in people with bone metastases from solid tumors. Sandoz’s application is for all of the drugs’ indications. Prolia’s list price is $1,564.31 per injection every six months, and the per-dose price for Xgeva — which is dosed every four weeks — is $2,877.36.
Elevance Health said on Feb. 15 that it had closed its acquisition of BioPlus, a specialty pharmacy subsidiary of CarepathRx, a portfolio company of Nautic Partners. BioPlus will operate as part of CarelonRx, Elevance’s PBM within Carelon, its health care services brand. Elevance said Nov. 9 that it had entered into an agreement to purchase the company. It did not disclose financial terms of the deal. The firm also said that it “plans to expand BioPlus’ service models across more complex disease treatment areas so the combined company can continue to provide timely access to medications, deliver leading support services for both providers and patients, and ensure individuals receive distinctive clinical expertise and service.