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Fresenius Kabi’s Stimufend (biosimilar, pegfilgrastim) Receives EC’s Approval for Oncology Indications

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Fresenius Kabi’s Stimufend (biosimilar, pegfilgrastim) Receives EC’s Approval for Oncology Indications

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  • The EC has granted marketing authorization for Stimufend (biosimilar, pegfilgrastim) in all approved indications of reference Neulasta. Stimufend is 1st approved product in oncology & is available as an affordable, high-quality treatment option in the EU
  • The approval was based on two trials evaluating Stimufend (biosimilar, pegfilgrastim) vs Neulasta which showed an equivalent PK, PD, safety & immunogenicity profiles to the reference Neulasta in healthy patients
  • The company plans to launch biosimilar Stimufend in a prefilled syringe in the multiple EU markets in the coming mos. & also applied for regulatory approval of pegfilgrastim biosimilar with the US FDA which is currently under review

Ref: Fresenius Kabi | Image: Fresenius Kabi

 

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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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