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FDA Approves Stimufend, a Biosimilar to Neulasta
Fresenius Kabi expects to launch Stimufend as a prefilled syringe early in 2023.
The FDA has approved Fresenius Kabi’s biosimilar Stimufend (pegfilgrastim-fpgk) for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The company expects to launch the product as a prefilled syringe early next year. Stimufend is a biosimilar of Amgen’s Neulasta. The company is also developing on-body injector for Stimufend.
“The FDA approval of our pegfilgrastim biosimilar is an important step to better support the treatment experience and clinical outcomes of cancer patients in the United States,” Michael Schönhofen, Ph.D., Fresenius Kabi’s chief operating officer. “With our portfolio, we contribute to the broader adoption of biosimilars and to a sustainable healthcare system in the United States.”
Stimufend is Fresenius Kabi’s first U.S.-approved therapy in its biosimilar portfolio.
Pegfilgrastim biosimilar is a supportive care medicine for patients with non-myeloid cancer. It stimulates the growth of certain white blood cells, which are essential to prevent or fight infections, a common life-threatening risk in patients receiving myelosuppressive chemotherapy.
The approval for Stimufend is based on a review of a comprehensive data package and a totality of evidence that demonstrated a high degree of similarity with the reference product. No clinically meaningful differences in safety and immunogenicity were observed
Stimufend received European Commission approval in March 2022.
Using the 'Pathway' Approach to Shorten the Time Between Cancer Diagnosis and Treatment
November 16th 2022In this episode of Tuning In to the C-Suite, Briana Contreras, editor with Managed Healthcare Executive spoke with Dr. Yuri Fesko, oncologist and vice president of Medical Affairs at Quest Diagnostics. In the conversation, Dr. Fesko addressed the ongoing issue of long gaps of times between receiving a diagnosis for a type of cancer and finally getting the treatment for it. Dr. Fesko shared the benefits a number of sectors receive when treating patients sooner and the steps to get there.
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FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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