European Commission Approves Pfizer's Pegfilgrastim Biosimilar

The European Commission (EC) has approved a Pfizer biosimilar for pegfilgrastim (Nyvepria), paving the way for marketing to begin. The drug is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in patients who have received chemotherapy treatment. The company said marketing is expected to begin in the first quarter of 2021.

The addition of Nyvepria will make 8 biosimilar pegfilgrastims available in the EU market vs 4 in the United States. Nyvepria received FDA approval for marketing in June of 2020. Febrile neutropenia is a common adverse event associated with cancer treatments and leaves patients vulnerable to infections, Pfizer explained in a statement about the EC approval.

“The development of febrile neutropenia in people living with cancer who are undergoing chemotherapy can be a very serious complication,” said Paul Cornes, MD, an oncologist and member of the continuing medical education program of the European Association of Hospital Pharmacists and core lecturer for the European School of Oncology. “The EC approval of Nyvepria provides clinicians with an alternative long-acting option that can help prevent infections.”

Pfizer said Nyvepria, the company’s sixth approved oncology biosimilar and third approved supportive care biosimilar in Europe, was approved following submission of comprehensive data package and on the basis of “totality of evidence” that demonstrated equivalence to the reference drug pegfilgrastim.

The reference product for pegfilgrastim is Amgen’s Neulasta, and this was separately approved by the FDA and the EC in 2002. Pegfilgrastim biosimilars began to appear on the European market in 2018, and there is now a crowded market for these products—in addition to Nyvepria, there are 7 pegfilgrastim biosimilars available for sale in Europe: Fulphila (2018, Mylan), Pelgraz (2018, Accord Healthcare), Pelmeg (2018, Cinfa Biotech), Udenyca (2018, Coherus), Ziextenzo (2018, Sandoz), Grasustek (2019, Juta Pharma), and Pegfilgrastim Multipharma (2019, Multipharma Biologics).

A report early this year described pegfilgrastim biosimilars as having achieved a 42% market share in Europe vs 29% in the United States, where Neulasta competes alongside Ziextenzo, Udenyca, Fulphia, and Nyvepria.

However, Amgen’s patented Neulasta Onpro wearable injector device for Neulasta has taken an increasing share of the market from biosimilar versions, which must be administered inside the clinic; and providers and industry observers say the convenience of Onpro for treatment of patients during the pandemic, when office visits have declined, has contributed to the growing use of this product. Neulasta Onpro had a 55% share of the US market for pegfilgrastim during the third quarter of 2020. Onpro was approved for use in the EU market in 2018.