Fresenius Kabi Launches Stimufend in the US

Fresenius Kabi announced that it has launched Stimufend, its biosimilar referencing Neulasta (pegfilgrastim), on the US market, making it the fifth pegfilgrastim biosimilar to become commercially available to American patients.

Stimufend (pegfilgrastim-fpgk) was approved by the FDA in September 2022. It was the sixth pegfilgrastim biosimilar to receive FDA approval and it was the second pegfilgrastim biosimilar, fourth oncology biosimilar, and fifth biosimilar overall to receive approval in 2022. Stimufend was also granted marketing authorization by the European Commission in March 2022.

The FDA approval came prior to the December 2022 approval for Fresenius Kabi’s adalimumab biosimilar Idacio (adalimumab-aacf). Stimufend was the first biosimilar developed by Fresenius Kabi to be approved for use in the United States.

“Fresenius Kabi is excited to launch Stimufend as it represents both our first biosimilar product in the U.S. and our long-term commitment to build a U.S. biosimilars business that supports patients, health care providers and payers….I am confident the introduction of Stimufend will be the first of many examples of our commitment to biosimilars in the U.S,” commented Ali Ahmed, senior vice president of biosimilars at Fresenius Kabi USA, in a company statement.

Pegfilgrastim products are used in the treatment and prevention of febrile neutropenia, a common and life-threatening adverse effect among patients with cancer undergoing chemotherapy. Stimufend is available in a single-dose, prefilled syringe that delivers 6 mg/0.6 mL solution for subcutaneous injection.

Fresenius Kabi is looking to get an additional approval for Stimufend in an on-body injector to compete against the on-body injector product for Neulasta (Neulasta Onpro). In the fourth quarter of 2019, Neulasta Onpro represented nearly 45% of all long-acting granulocyte colony-stimulating factor prescriptions, considerably higher than those for pegfilgrastim biosimilars (29.8%).

“The FDA approval of Stimufend was based on the totality of evidence supporting its biosimilarity to Neulasta. Health care providers and patients can be confident in Stimufend as a treatment option given its proven structural, functional and clinical similarity, including highly similar safety and tolerability profiles…. Equally important to the clinical development of Stimufend is Fresenius Kabi’s dedication to providing patients with ongoing support,” said Brandee Pappalardo, PhD, MPH, senior vice president and chief medical officer for Fresenius Kabi USA.

The other pegfilgrastim biosimilars on the market include Nyvepria (pegfilgrastim-apgf; Pfizer), Ziextenzo (pegfilgrastim-bmez; Sandoz), Udenyca (pegfilgrastim-cbqv; Coherus Biosciences), and Fulphila (pegfilgrastim-jmdb; Viatris/Biocon Biologics). Fylnetra (pegfilgrastim-pbbk, Amneal Pharmaceuticals) is FDA approved but has not entered the market yet.

In addition to Stimufend and Idacio, Fresenius Kabi has submitted biologics license applications for a tocilizumab (Actemra) biosimilar candidate (MSB11456). Fresenius Kabi also launched Idacio on the Canadian market in February 2021.