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

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

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

Biosimilares/Novedades | Posted 12/06/2020 0 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.

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

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.

Source: Fresenius Kabi