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Business & Regulation Business Practice, Standards & Regulation, Biosimilars

Biosimilars’ 2020 Breakthrough?

The FDA has approved Pfizer’s Nyvepria (pegfilgrastim-apgf), a biosimilar of Amgen’s oncology supportive care drug, Neulasta. The approval is the FDA’s fourth for a biosimilar pegfilgrastim – and the first biosimilar approval for 2020. The drug, which is approved to prevent infection in patients receiving myelosuppressive anticancer drugs, has also been submitted to the EMA for review.

Although Pfizer plans to market the drug in the US later this year, Nyvepria is also the subject of ongoing litigation. Earlier this year, Amgen announced it was suing Pfizer over allegations that, when developing Nyvepria, Pfizer’s Hospira unit infringed on a Neulasta patent focusing on protein purification. Originally scheduled for June 2020, the trial has been postponed until May 2021. All previous biosimilar pegfilgrastim drugs have also faced lawsuits from Amgen.

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  1. Pfizer, “FDA Approves Pfizer’s Oncology Supportive Care Biosimilar, Nyvepria (Pegfilgrastim-apgf)” (2020). Available at bit.ly/2AbOY6T.
  2. FDANews, “Amgen Sues Pfizer, Hospira in Neulasta Patent Dispute” (2020). Available at bit.ly/2VqrIcY.

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