Biosimilars Lead to Sales Declines, New Opportunities for Amgen

The fourth-quarter and full-year 2017 earnings report from Amgen highlights the fact that biosimilars can be both a challenge and an opportunity for drug makers whose innovator products face biosimilar competition and who develop biosimilar products of their own.

Filgrastim Sales Decline After Biosimilar Competition

Fourth-quarter sales of Neupogen (filgrastim) declined 27% year-over-year and 9% quarter-over-quarter, with unit declines of the innovator drug driven by competition from biosimilar therapies, including Sandoz’s Zarxio in the United States. Neupogen now holds approximately a 40% unit share of filgrastim in the US marketplace.

Sales of Amgen’s pegfilgrastim, Neulasta, were flat year-over-year, and sales of the drug’s Onpro presentation (an on-body injector) accounted for slightly more than 60% of pegfilgrastim sales. Amgen says that it expects the drug to see a slow decline as myelosuppressive chemotherapy regimens give way to newer immunotherapies, but did not name the threat of biosimilar competition as a concern.

Oncoming Biosimilar Challenge to Aranesp

Amgen also saw fourth-quarter sales of its Aranesp (darbepoetin alfa) decline by 7% year-over-year, and 5% quarter-over-quarter, with lower unit demand for the drug playing a role in this sales slowdown. Amgen says that it is closely monitoring both emerging long-acting erythropoiesis-stimulating agents, which could compete with Aranesp for market share, as well as the potential for a short-acting biosimilar to be launched in the United States.

Oncology and Rheumatology Biosimilars Ahead

Looking ahead, Amgen sees room for biosimilars to boost its business, especially with its upcoming 2018 launch of Amjevita, a biosimilar adalimumab, in the European Union. Also ahead—though no date has yet been announced—is the launch of Mvasi, a biosimilar bevacizumab that has been approved in the United States and the European Union.

Finally, Amgen expects to announce data from a phase 3 study of its proposed infliximab biosimilar, ABP 710, in the second half of 2018, and the drug maker also anticipates approval of its Biologics License Application for ABP 980, a proposed trastuzumab biosimilar, which has a Biosimilar User Fee Act target action date of May 28, 2018.