Tags : MSB11455

Biosimilars

Fresenius Kabi Reports the US FDA’s Acceptance of BLA for

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 […]Read More

Biosimilars Regulatory

Fresenius Kabi Reports EMA’s Acceptance of MAA for its MSB11455

Shots: The MAA submission of the MSB11455 includes the results of two pivotal clinical trials including bioequivalent PK & PD data with similar immunogenicity results and includes analytical plus safety data which was comparable to pegfilgrastim Fresenius Kabi’s attempt to submit MAA is another milestone following last year’s approval and launch of the company’s adalimumab […]Read More