Big Molecule Watch
February 3, 2017

Amgen Reports on Neulasta, Neupogen Biosimilar Competition and Acceptance of Avastin Biosimilar aBLA

On yesterday’s earnings call for Q4 2016, Amgen indicated that it is projecting its Neulasta® (pegfilgrastim) product to face biosimilar completion in the U.S. by the end of the year.  According to Amgen Executive Vice President and CFO David Meline, Amgen is operating under the assumption of “biosimilar competition against Neulasta commencing in the fourth quarter” of 2017.  Anthony Hooper, Executive Vice President for Global Commercial Operation, further explained Amgen does “not expect any long-acting biosimilar competition until fourth quarter 2017, assuming the current interpretation of the 180 days [prior notice of first commercial marketing] is upheld [by the United States Supreme Court].”  Although FDA has accepted aBLAs for Neulasta® biosimilars from Apotex, Sandoz and Coherus, FDA has yet to approve any of those applications, and Amgen did not report from which company (or companies) it is projecting biosimilar competition.

Amgen also reported year-over-year declines in both unit sales and net sales of its Neupogen® (filgrastim) product, which has faced biosimilar competition in the U.S. from Sandoz’s Zarxio® (filgrastim-sndz) since September 2015.  Compared to Q4 2015, unit and net sales worldwide were down 25% and 34%, respectively, and U.S. net sales were down 43%.  According to Amgen, “[u]nit declines [were] driven by U.S. biosimilar competition, which are expected to continue.”

Amgen further reported that last month FDA accepted its aBLA for ABP 215, Amgen and Allergan’s proposed biosimilar of Avastin® (bevacizumab).  Amgen reports that the application, which was submitted in November 2016, now has a BsUFA target action date of September 14, 2017.