FDA Accepts Fresenius Kabi Pegfilgrastim Biosimilar Candidate for Review

Fresenius Kabi announced on May 27, 2020 that the FDA “accepted for review the company’s Biologics License Application (BLA) for MSB11455,” a biosimilar candidate of NEULASTA (pegfilgrastim).  According to the press release, this is Fresenius Kabi’s first biosimilar candidate submitted to the FDA.

Fresenius Kabi also received acceptance for review of its submission for Marketing Authorization Application for the same biosimilar candidate from the EMA earlier this month.

 

 

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