Pfizer’s Pegfilgrastim Biosimilar Approved by the FDA

The ranks of the pegfilgrastim biosimilar competition is filling out, with the latest approval by the Food and Drug Administration. Pfizer announced the approval of its product Nyvepria™ on June 11.

Officially designated pegfilgrastim-apgf, Pfizer has not yet announced a launch date for this agent. However, in its press release, Andy Schmeltz, Global President, Pfizer Oncology, stated, “We look forward to making Nyvepria available to US patients and physicians later this year.” The company submitted its 351(k) application for the agent in the third quarter of 2019.

Pfizer pegfilgrastim biosimilar

The indications for use of Nyvepria mirror those for the other pegfilgrastim biosimilars. In addition, the adverse events listed in the prescribing information are essentially those of other pegfilgrastim competitors.

The 27th biosimilar approval, Nyvepria is the fourth pegfilgrastim biosimilar to receive the FDA’s nod. Another agent, developed by Fresenius Kabi, is not expected to receive an FDA decision until the second quarter of 2021. Nyvepria was a legacy product from Pfizer’s acquisition of Hospira, and originally designated HSP-130 (but changed to PF-06881854).

Pfizer’s pegfilgrastim biosimilar submission application included a package of data derived from its analytical and characterization research as well from two phase 1 studies in healthy volunteers, which helped to establish the similarity of this agent to the reference agent. [A clarification to this story was posted 6/18: Additionally, an open-label phase 1/2 study was conducted with HSP-130 in patients with nonmetastatic breast cancer, which also tested the pharmacokinetics and pharmacodynamics of the agent. This trial did not compared the results with those of a reference product]. 

Nyvepria is the ninth FDA-approved biosimilar in Pfizer’s portfolio (including two versions of infliximab: Inflectra®, which it markets for Celltrion, and Infixi®, which is not marketed in the US).

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