FDA clears mAbxience–Amneal denosumab biosimilars, opening a new front in osteoporosis and oncology pricing

FDA clears mAbxience–Amneal denosumab biosimilars, opening a new front in osteoporosis and oncology pricing

mAbxience and Amneal Pharmaceuticals have secured U.S. Food and Drug Administration (FDA) approval for two denosumab biosimilars, Boncresa and Oziltus, referencing Prolia and XGEVA respectively, clearing a long-anticipated regulatory hurdle in osteoporosis and oncology supportive care. The approvals position Amneal Pharmaceuticals as the exclusive U.S. commercial partner, with mAbxience responsible for development and manufacturing, marking […]

Amgen adds Aimovig and Amjevita to TrumpRx platform in latest move to defuse U.S. pricing pressure

Amgen adds Aimovig and Amjevita to TrumpRx platform in latest move to defuse U.S. pricing pressure

Amgen has expanded its direct-to-patient program, AmgenNow, to include Aimovig (erenumab-aooe) and Amjevita (adalimumab-atto), each now available at a flat monthly price of $299 for eligible U.S. patients. This development forms part of Amgen’s broader agreement with the Trump Administration, satisfying conditions laid out in the President’s July 31 policy letter and positioning the company […]

Can Gotenfia finally unlock biosimilar competition for Simponi in Europe?

Can Gotenfia finally unlock biosimilar competition for Simponi in Europe?

STADA Arzneimittel AG and Bio-Thera Solutions have secured a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Gotenfia, a proposed biosimilar to the tumor necrosis factor alpha inhibitor golimumab. The product references Simponi, an originator drug widely prescribed for multiple autoimmune conditions. If approved, Gotenfia would be marketed […]