A second clinical trial designed to evaluate the biosimilar B12019 to treat chemotherapy-induced neutropenia met its primary and secondary endpoints, according to the agent’s manufacturer.
B12019 (Cinfa Biotech) is a biosimilar version of pegfilgrastim (Neulasta, Amgen), a pegylated granulocyte colony–stimulating factor receptor agonist used to stimulate bone marrow to produce more neutrophils to decrease infection incidence in patients who undergo chemotherapy.
A randomized, multiple-dose, double blind, three-period crossover study compared B12019 with pegfilgrastim in 96 healthy volunteers in Germany.
B12019 demonstrated similar pharmacodynamics and immunogenicity compared with pegfilgrastim. In addition, the safety profile of B12019 appeared consistent with that of pegfilgrastim.
Additional data from the study will be presented at future scientific conferences.
“The positive results of our second study confirm the biosimilarity of B12019 and Neulasta that we demonstrated in the first trial,” Ruediger Jankowsky, PhD, managing director of Cinfa Biotech, said in a company-issued press release. “Both studies, together with the analytical and functional comparability data, support the high quality of our product candidate.”