Spanish biosimilars company Cinfa Biotech has reported positive top-line clinical trial results of B12019, a biosimilar version of Neulasta (pegfilgrastim), to treat chemotherapy-induced neutropenia.
The single-dose, randomised, double-blind, cross-over trial involved 172 healthy volunteers in Germany.
The trial was primarily focused to determine the pharmacokinetic (PK) and pharmacodynamic (PD) profile of B12019 when compared with Neulasta.
The secondary endpoint of the trial was to evaluate the safety and immunogenicity of B12019.
Both B12019 and Neulasta have displayed safety, tolerability and immunogenicity.
Cinfa Biotech managing director Dr Ruediger Jankowsky said: "We are pleased to have achieved this significant milestone in the development of our first biosimilar candidate B12019.
"All endpoints of the clinical trial have been met, confirming the high quality of our product candidate. These positive results confirm our development strategy, which is based on most up-to-date scientific considerations and includes a second clinical study to investigate the immunogenicity of B12019.
"We will now accelerate the establishment of partnerships for commercialisation as we expect a timely submission for approval in Europe."
Pegfilgrastim is developed to treat chemotherapy-induced neutropenia.
It consists of the pegylated granulocyte colony-stimulating factor (G-CSF) receptor agonist, which stimulates bone marrow to produce more neutrophils to decrease the incidence of infections in patients undergoing chemotherapy.