In an in-vivo study involving 16 New Zeeland White rabbits Xlucane (ranibizumab (Lucentis) biosimilar) demonstrated equivalent tolerability and pharmacokinetic profile in the serum and in the vitreous body compared to the reference product Lucentis.
Design of the study
The objective of the study was to compare the pharmacokinetic profile and tolerability between Xlucane and the reference product Lucentis. The study involved 16 New Zeeland White rabbits, divided in two equally sized groups, where each rabbit received a single bilateral intravitreal injection of Xlucane and Lucentis respectively. Tolerability was monitored via ophthalmologic examinations on all animals throughout the study as well as via histopathology at selected timepoints to observe potential inflammations at microscopical level. The pharmacokinetic profile, i.e. the concentration of the active substance ranibizumab over time, was measured in the serum of the animals throughout the study as well as in the vitreous body.
An equivalent pharmacokinetic profile was observed in the Xlucane group compared to the Lucentis group both measured in the serum as in the vitreous body. Eyes treated with Xlucane did not develop any ocular inflammation and the product was well tolerated.
“We are very pleased with the result of this study as it demonstrates an equivalent tolerability and pharmacokinetic profile of Xlucane compared to the reference product. This, combined with the excellent comparable in-vitro analytical data previously announced, gives us full confidence ahead of the upcoming pivotal clinical equivalence trial.” says Martin Åmark, CEO Xbrane.
The study was performed by Charles River Laboratories.