Cinfa Biotech reports clinical development data for pegfilgrastim biosimilar B12019 at ESMO 2017

September 6, 2017 8:33 AM


Cinfa Biotech S.L., the biosimilars company of Cinfa Group, reports further data of the clinical development program for its lead development candidate B12019.

B12019 is a biosimilar version of Neulasta (pegfilgrastim) to treat chemotherapy-induced neutropenia, during a poster presentation at the European Society for Medical Oncology (ESMO) Congress 2017 in Madrid, Spain, from September 8-12, 2017.

The poster 1573P titled: “Pharmacokinetic and Pharmacodynamic Comparability of B12019, a Proposed Pegfilgrastim Biosimilar will be presented on September 10, 2017.

The data to be presented will provide the scientific basis for submitting the EMA marketing authorisation application. The clinical development program for B12019 was based on scientific advice from EMA and included two clinical studies.

The pivotal study examined pharmacokinetic (PK) and pharmacodynamic (PD) comparability of 6 mg B12019 to 6 mg Neulasta. The single-dose, randomised, double-blind, two-way cross-over study enrolled 172 healthy volunteers. The primary endpoints were the area under the plasma concentration-time curve and the maximum concentration for PK and the area under the effect curve (AUEC) for absolute neutrophil count for PD.

The supportive study examined immunogenicity and PD comparability of 3 mg B12019 and 3 mg Neulasta in a multiple-dose, randomised, double-blind, three-period, two-sequence cross-over study in 96 healthy volunteers. Primary endpoints were AUEC for PD and anti-drug antibody rate for immunogenicity.

All clinical endpoints were met in both studies.

PK comparability was demonstrated in the pivotal study, and PD comparability was demonstrated in both studies. No imbalance of ADA-positive samples was observed and neither anti-G-CSF nor neutralising antibodies were detected for B12019 or Neulasta in both studies.

The clinical program confirmed the biosimilarity of B12019 and Neulasta in highly sensitive clinical study settings, thereby verifying the high level of similarity as shown on bioanalytical level.

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