Fresenius Kabi Reports the US FDA’s Acceptance of BLA for its MSB11455 (biosimilar, pegfilgrastim)

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)