Fresenius Kabi’s biosimilar Stimufend obtains FDA OK

Fresenius Kabi, a global healthcare company that specializes in pharmaceuticals, medical technologies and nutrition products for critical and chronic conditions, has received the Food and Drug Administration’s green light for its pegfilgrastim biosimilar, Stimufend.

The medication is indicated for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

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An expected launch of the product in a prefilled syringe early next year and in an on-body injector following FDA approval, the company said. 

“This is a strategic milestone for Fresenius Kabi in one of the most important and fast-growing markets for biopharmaceuticals,” said Michael Sen, CEO of Fresenius Kabi and designated CEO of Fresenius. “The company consequently expands its presence and position in the highly attractive U.S. biosimilars marketplace in line with Vision 2026.”

Stimufend is Fresenius Kabi’s first U.S.-approved therapy in its biosimilar portfolio. The 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 company said. 

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“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," said Michael Schönhofen, Fresenius Kabi’s chief operating officer and member of the Fresenius Kabi management board. "With our portfolio, we contribute to the broader adoption of biosimilars and to a sustainable healthcare system in the United States.”