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