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J Clin Exp Tox 2017 | Volume 1 | Issue 2
Toxicology and Pharmacology
November 01-02, 2017 | Toronto, Canada
International Conference on
Safety and biosimilarity of ior®LeukoCIM compared to Neupogen® based on toxicity, pharmacodynamic
and pharmacokinetic studies in the Sprague-Dawley rat
Nuris Ledon
2
, Albert Licollari
1
, Katherine Riddle
1
, Simon R Taylor
1
and
Gordon T Bolger
1
1
Nucro-Technics, Canada
2
Centre of Molecular Immunology, Cuba
T
his study examined the safety, pharmacodynamic and
pharmacokinetic biosimilarity of the human recombinant
filgrastim products iorRLeukoCIM and NeupogenR following
a 28-day repeated subcutaneous dose administration in male
and female Sprague-Dawley rats with a 14- day recovery
period. Safety profiling was based on clinical observations,
clinical pathology and pathology findings for control rats
dosed with vehicle and rats dosed either with 15, 75 and 150
μg/kg of iorRLeukocim or 150 μg/kg of NeupogenR. Adverse
clinical findings for both iorRLeukoCIM and NeupogenR
were similar and consisted of mild to moderate forelimb
alopecia; skin lesions (scab formation on the shaved dorsal
region) and mild to severe swelling of the hock-joint (tarsal
joint) and hind limb, alone or accompanied with lameness
in high dose group animals which was more prominent
in males. All adverse findings were fully reversible. As
expected, iorLeukoCIMR and NeupogenR both increased
white blood cell and neutrophil levels in rats and to a
similar extent for high dose iorRLeukoCIM and NeupogenR.
The pharmacokinetics of filgrastim following dosing with
iorRLeukoCIM was well behaved and comparable for high
dose iorRLeukoCIM and NeupogenR. The results of this
study imply that iorRLeukoCIM and NeupogenR had safety
profiles, pharmacodynamic responses and toxicokinetic
profiles that were biosimilar.
Speaker Biography
Nuris Ledon has a PhD in Pharmaceutical Sciences since 2000. She is also an Auxiliary
Professor and Senior Researcher at Molecular Immunology Center, La Havana,
Cuba with 25 years of experience. She counts with two Master´s degrees, one in
Pharmacology and other in Business Administration. She has published more than
50 articles on subjects like Pharmacology and Toxicology of different drugs. She has
participated in numerous congress and summits and has tutored several theses.
e:
Nuris@cim.sld.cu