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Positive phase I results for Fresenius Kabi’s pegfilgrastim biosimilar Posted 07/12/2018

Fresenius Kabi, one of the independently operated business segments of global healthcare group Fresenius, announced on 9 October 2018 that results from two phase I studies of its pegfilgrastim biosimilar (MSB11455) had met their primary endpoints.

The first study was a randomized, double-blind, crossover study that compared the pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence of a single injection of MSB1145 compared to the originator pegfilgrastim Neulasta in healthy adult subjects in Australia.

A total of 344 healthy volunteer subjects were randomized to one of two treatment arms and received a single dose of first MSB11455 then Neulasta or a single dose of first Neulasta then MSB11455. The study was completed in October 2018.

Fresenius Kabi said that this study ‘met all primary pharmacokinetic endpoints, Cmax and area under the curve (AUC), as well as the primary pharmacodynamic endpoints of absolute neutrophil count (ANC). Similar adverse events were found in both treatment groups.’

The second study investigated the safety and immunogenicity of MSB11455. It was a randomized, double-blind, parallel group, controlled study to compare the immunogenicity and safety of MSB11455 and Neulasta in healthy adult subjects in New Zealand.

A total of 344 healthy volunteer subjects were randomized to one of two treatment arms and received a single dose of first MSB11455 then Neulasta or a single dose of first Neulasta then MSB11455. The study was completed in September 2018.

Fresenius Kabi said that this second study ‘met its primary endpoints for immunogenicity. Positive anti-drug antibodies status was balanced between both treatment groups and no neutralizing antibodies were found. Similar adverse events were observed in both study arms.’

Fresenius Kabi gained MSB11455 after it acquired the entire development pipeline of Merck KGaA’s biosimilars, along with employees located in Aubonne and Vevey, Switzerland, in September 2017 [1].

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Fresenius Kabi acquires Merck KGaA’s biosimilars business [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Pharma-News/Fresenius-Kabi-acquires-Merck-KGaA-s-biosimilars-business

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Source: ClinicalTrials.gov, Fresenius Kabi

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