Fresenius Kabi’s Stimufend (biosimilar, pegfilgrastim) Receives the US FDA Approval for Non-Myeloid Malignancies
Shots:
- The US FDA has approved Stimufend, a biosimilar referencing Neulasta for non-myeloid malignancies who received myelosuppressive anti-cancer drugs associated with the incidence of FN. The product will be available in the US as a prefilled syringe & in an on-body injector in early 2023
- The approval was based on a comprehensive data package & totality of evidence that showed comparable safety & efficacy of Stimufend vs Neulasta with no clinical differences
- The company received the EC's marketing authorization for Stimufend in 2022 & is expected to launch its pegfilgrastim biosimilar in a prefilled syringe in the EU. In addition to Stimufend, the BLA for tocilizumab biosimilar & adalimumab are currently under the US FDA’s review
Ref: Fresenius Kabi | Image: Fresenius Kabi
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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.
