Cinfa Biotech's B12019 Similar to Neulasta in Terms of PD, Immunogenicity

Researcher Karsten Roth, PhD, and his team will present at the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, on December 9, 2017, the findings of a study that found that Cinfa Biotech’s proposed pegfilgrastim biosimilar, B12019, has similar pharmacodynamics (PD) and immunogenicity to the reference Neulasta.¹

B12019 is being developed as a biosimilar to Neulasta, which is a long-acting form of recombinant human granulocyte-colony stimulating factor (G-CSF) filgrastim for the prevention of chemotherapy-induced neutropenia. Cinfa’s clinical development program, based on scientific advice from the European Medicines Agency, consists of 2 clinical studies conducted to confirm the biosimilarity to the EU-authorized reference product as established by analytical, functional, and preclinical data. This study investigates the immunogenicity and pharmacodynamic comparability of the biosimilar and reference at a dose of 3mg.

A dose of 3mg was selected for the study because it is more sensitive to detect potential differences in PD between the biosimilar and the reference product, as compared to the clinical dose of 6mg. This study was designed as a multiple-dose, randomized, double-blind, 3-period, 2-sequence cross-over study in 96 healthy individuals.

A hierarchical ADA test strategy with highly sensitive screening assay followed by 4 parallel epitope-specific, confirmatory assays was established. Primary study endpoints were AUEC_0-last of the absolute neutrophil count for PD after cross-over and the anti-drug antibody rate for immunogenicity after repeat dosing.

The number of ADA-positive subjects was very low for both the B12019 and Neulasta groups. No imbalance was observed between the either of the study drugs after repeat doses. Neither anti-filgrastim nor neutralizing antibodies were detected for B12019 or Neulasta. In the model-based PD comparison, 82 subjects were included. PD comparability was demonstrated, and there were no clinically meaningful differences observed in the safety profile for B12019 and Neulasta.

This study of the prospective biosimilar to the reference pegfilgrastim confirmed PD comparability with the reference product at a sensitive dose of 3mg, and the researchers concluded that the study confirmed biosimilarity of the proposed biosimilar to the reference.

Reference

1. Roth K, Wessels H, Hoefler J, Jankowsky R. Comparability of pharmacodynamics and immunogenicity of B12019, a proposed pegfilgrastim biosimilar to Neulasta. Presented at the American Society of Hematology 59th Annual Meeting and Exposition 2017, December 9, 2017; Atlanta, GA. Abstract 1002. https://ash.confex.com/ash/2017/webprogram/Paper100922.html