Lead Product(s) : Pegfilgrastim
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Accepts for Review Fresenius Kabi’s BLA Submission for Pegfilgrastim Biosimilar
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).
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
May 27, 2020
Lead Product(s) : Pegfilgrastim
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Pegfilgrastim
Therapeutic Area : Hematology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Fresenius Kabi’s Regulatory Submission for Pegfilgrastim Biosimilar Accepted for Review By EMA
Details : Fresenius Kabi’s MAA submission for pegfilgrastim biosimilar candidate includes analytical, pharmacokinetic, pharmacodynamic, safety and immunogenicity data.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
May 22, 2020
Lead Product(s) : Pegfilgrastim
Therapeutic Area : Hematology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable