Fresenius Kabi’s pegfilgrastim biosimilar accepted for review by EMA and FDA

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 22 and 27 May 2020 that the regulatory submissions for its proposed pegfilgrastim biosimilar (MSB11455) had been accepted by both EMA and FDA, respectively.

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

Fresenius Kabi’s submissions for the pegfilgrastim biosimilar candidate includes analytical, pharmacokinetics (PK), pharmacodynamics (PD), safety and immunogenicity data. The application includes the results of two pivotal clinical trials that showed equivalent PK and PD profile to pegfilgrastim, as well as similar immunogenicity in healthy volunteers. The safety profile of MSB11455 was also comparable to pegfilgrastim.

Fresenius Kabi already has two biosimilars approved in the European Union. Adalimumab biosimilars for the treatment of arthritis, Idacio and Kromeya, were approved in April 2019 [1]. This pegfilgrastim biosimilar submission will mark the company’s first approval in the US.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilars Idacio and Kromeya [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 12]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilars-Idacio-and-Kromeya

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