FDA Approves Autoinjector Version of Neulasta Biosimilar

Coherus Biosicences announced that the FDA approved a single-dose, prefilled autojector version of its pegfilgrastim biosimilar (Udenyca; pegfilgrastim-cbqv), for the treatment and prevention of febrile neutropenia, a common complication related to chemotherapy treatment.

The autoinjector device will allow for patients to be administered pegfilgrastim the day after receiving chemotherapy, decreasing the risk of patients developing febrile neutropenia. The Udenyca autoinjector is triggered by push-on-skin activation, allowing for reliable and immediate delivery of a full pegfilgrastim dose.

“The Udenyca autoinjector represents the first innovation in the pegfilgrastim space in eight years and highlights Coherus’ commitment to developing innovative solutions that expand access and address the needs of patients undergoing cancer treatment,” said Denny Lanfear, CEO of Coherus Biosciences, in a statement.

The original version of Udenyca was approved in November 2018 and launched on the US market in January 2019. It is 1 of 6 FDA-approved biosimilars referencing Amgen’s Neulasta.

In addition to the 2 FDA-approved presentations for the biosimilar, another application for an on-body injector version is under review. According to Amgen, sales of originator Neulasta has been declining due to the market introduction of pegfilgrastim biosimilars. However, shares of Neulasta Onpro have been steady, achieving 58% of the pegfilgrastim market share during the second quarter of 2020.

The autoinjector approval comes after the US launch of Stimufend (pegfilgrastim-fpgk). Stimufend received approval in September 2022. The biosimilar’s manufacturer, Fresenius Kabi, has also expressed that it is looking to get an additional approval for an on-body injector for Sitmufend.

In Coherus’ statement, Lee Schwartzberg, MD, FACP, chief of medical oncology and hematology at the Renown Health William N. Pennington Cancer Institute and professor of clinical medicine at the University of Nevada, argued that the introduction of Udenyca with an autoinjector option will be especially helpful for patients who have difficulties getting to a doctor’s office for regular pegfilgrastim injections.

“The introduction of the autoinjector option for Udenyca…will provide increased choice and control for patients and physicians, ultimately making treatment more accessible to patients…. There are certain types of cancer patients, those who live far away, have an active lifestyle, or who are supporting the needs of a busy family, for whom this option eliminates the need to return to the clinic and enables them to choose the time and place for treatment without having to wear an on-body device,” said Schwartzberg.

In addition to Udenyca, Coherus has launched the first ranibizumab biosimilar to have an interchangeability designation (Cimerli) in October 2022. Coherus also has an aflibercept biosimilar (FYB203) referencing Eylea in development and an adalimumab biosimilar (Yusimry) ready to launch in July 2023.