AMGN · 10-Q · 2026Q3 · Full report

Prolia Biosimilar Competition

AMGEN INC · 2026-11-04 · Importance 84 · Surprise 74

Prolia sales fell 45% globally in the third quarter and 37% in the first nine months of 2026 as multiple biosimilars launched in the U.S. and ROW. Nine-month sales declined to $2.118 billion from $3.360 billion. The quarterly decline reflected 23% lower volume, with the remainder driven equally by lower net selling price and changes to estimated sales deductions; the nine-month decline was primarily driven by 20% lower volume and a 13% lower net selling price. Amgen expected continued sales erosion for the remainder of 2026 amid increased biosimilar competition.

Key facts

• Global Prolia sales decreased 45% in the three months and 37% in the nine months ended September 30, 2026, as multiple biosimilars launched in the United States and ROW. source
• A claim construction hearing in Amgen’s Prolia/XGEVA BPCIA litigation is to be scheduled after November 19, 2027; the joint pretrial order is due September 15, 2028, and no trial date has been set. source
• Global Prolia sales decreased in the three months ended September 30, 2026, driven by lower volume of 23%, with the remainder driven equally by lower net selling price and changes to estimated sales deductions. source
• Global Prolia sales decreased in the nine months ended September 30, 2026, primarily driven by lower volume of 20% and lower net selling price of 13%. source
• Amgen expects continued Prolia sales erosion for the remainder of 2026 due to increased competition from multiple biosimilars launched in the United States and ROW. source
• Patents for RANKL antibodies, including sequences, for Prolia and XGEVA expired in February 2025 in the United States and in November 2025 in select European countries. source