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Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2020
Details:
U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for MSB11455, a biosimilar candidate of Neulasta®* (pegfilgrastim).
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Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 22, 2020
Details:
Fresenius Kabi’s MAA submission for pegfilgrastim biosimilar candidate includes analytical, pharmacokinetic, pharmacodynamic, safety and immunogenicity data.
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