Fresenius Kabi launches first biosimilar in the U.S.

16 Feb 2023

·www.fresenius.com

Drug ApprovalBiosimilarImmunotherapy

Fresenius Kabi’s Biosimilar Stimufend® (pegfilgrastim-fpgk) is now available from Fresenius Kabi in the United States. Stimufend® was approved by the U.S. Food and Drug Administration (FDA) in September 2022 for use in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. It is Fresenius Kabi’s first U.S. biosimilar launch. The expansion of the company’s global biosimilars portfolio with a focus on oncology and immunology is an important milestone in its Vision 2026 growth strategy.

* Stimufend® (pegfilgrastim-fpgk) is a registered trademark of Fresenius Kabi Deutschland GmbH in selected countries. Stimufend is a pegfilgrastim biosimilar medicine of Neulasta®, which is a registered trademark of Amgen Inc.

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Organizations

Fresenius Kabi Oncology Ltd.

US Food & Drug AdministrationFresenius Kabi Deutschland GmbH

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Indications

Febrile Neutropenia

Targets

Drugs

Pegfilgrastim biosimilar(Fresenius Kabi)Pegfilgrastim (Amgen)

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