Shots:

• The BLA submission is based on analytical- PK/ PD- safety and immunogenicity data from two clinical studies that demonstrated equivalent PK/ PD profile to Neulasta- similar immunogenicity & comparable safety profile in healthy volunteers
• The BLA represents Fresenius Kabi’s first biosimilar candidate submitted to the FDA. Additionally- Fresenius Kabi also received EMA’s acceptance for review MAA of MSB11455 on May 22- 2020
• MSB11455 is a biosimilar referencing Amgen’s Neulasta- acts by stimulating the growth of WBCs. Neulasta is indicated to decrease the incidence of infection- as manifested by febrile neutropenia- in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with febrile neutropenia in the US

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Related News: Fresenius Kabi Reports EMA’s Acceptance of MAA for its MSB11455 (biosimilar- pegfilgrastim)