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

Biosimilares/Novedades | Posted 12/06/2020 post-comment0 Post your comment

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 the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), respectively.

Pegfilgrastim V16B19

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.

Related articles
Biosimilars approved in the US

Biosimilars of pegfilgrastim

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2020 Pro Pharma Communications International. All Rights Reserved.

Source: Fresenius Kabi

comment icon Comments (0)
Post your comment
Related content
EC and FDA approval for first ranibizumab biosimilar Byooviz
Age-related macular degeneration V15b19
Biosimilares/Novedades Posted 24/09/2021
Bevacizumab biosimilars launched in Spain and Korea
Turkey 2016 COVER V16E31DG
Biosimilares/Novedades Posted 17/09/2021
Mabpharm gains approval for infliximab biobetter in China
22119008_l
Biosimilares/Novedades Posted 10/09/2021
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010