In September last year, Stimufend received approval from the US Food and Drug Administration (FDA) to be used in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs that are associated with a clinically significant febrile neutropenia incidence.
Fresenius Kabi commercially launched Stimufend in a 6 mg/0.6 mL solution in a single-dose pre-filled syringe along with a passive needle guard.
The launch provides accessible and quality treatment option for cancer patients in the country who are undergoing chemotherapy.
Fresenius Kabi acting CEO Michael Sen said: “Fresenius Kabi’s first biosimilars launch in the US is a proud moment and a significant key milestone for us and our Vision 2026.
“We are expanding into a highly important and fast-growing market for biopharmaceuticals and Stimufend is the first of our biosimilars portfolio to support cancer patients in the US.
“Stimufend offers healthcare providers a high-quality treatment alternative while contributing to a sustainable healthcare system in the US.”
The company launched its pegfilgrastim biosimilar last October in a prefilled syringe in France after it secured marketing authorisation from the European Commission (EC) in March.
Stimufend is a leukocyte growth factor that is indicated for reducing the incidence of infection in patients with non-myeloid malignancies.
Fresenius Kabi chief operating officer Fresenius Kabi management board member Dr Michael Schönhofen said: “We are excited to provide this supportive care option to US patients and physicians via our dedicated US biosimilars organisation. This launch is a testimonial of our heritage in oncology and our commitment to oncology patients across the world.”
Stimufend is not indicated to mobilise peripheral blood progenitor cells for hematopoietic stem cell transplantation.