Pegfilgrastim Biosimilar Shows Comparability in Pharmacodynamics, Immunogenicity

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There are no clinically meaningful differences in the safety profile of B12019 and pegfilgrastim, according to study findings presented at the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia.

At the 59th American Society of Hematology Annual Meeting and Exposition in Atlanta, Georgia, findings on Cinfa Biotech’s B12019, a proposed biosimilar to pegfilgrastim (Neulasta), were presented.

B12019 is currently being developed as a biosimilar to pegfilgrastim, a pegylated, long-acting recombinant human granulocyte-colony stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia. Based on advice from the European Medicines Agency (EMA), the researchers conducted a clinical development program, consisting of 2 clinical studies, to assess B12019. The studies sought to determine if B12019 has biosimilarity to the EU-authorized pegfilgrastim.

The multiple-dose, randomized, double-blind, 3-period, 2-sequence crossover study, B12019-102 investigated the immunogenicity and pharmacodynamics (PD) comparability of the biosimilar and its reference drug. The 96 participants were administered a reduced dose of 3 mg. According to the authors, they chose a dose of 3 mg because it is considered more sensitive to detect potential differences between B12019 and pegfilgrastim than the clinical dose of 6 mg.


The authors used a hierarchical ADA test strategy with a highly sensitive screening assay followed by 4 parallel epitope-specific, confirmatory assays. They assessed AUEC0-last of the absolute neutrophil count for PD after crossover and anti-drug antibody rate for immunogenicity after repeat dosing.

The authors found that the number of ADA-positive subjects was low for both B12019 and pegfilgrastim participants. There was no observed imbalance between the drugs after repeated dosing. In addition, no anti-filgrastim nor neutralizing antibodies were seen for either drug. PD comparability was determined, with the AUEC0-last geometric mean ratio with a 95% CI of 99.58; 103.63 being within the pre-specified acceptance range.

The authors concluded that there were no clinically meaningful differences in the safety profile of B12019 and pegfilgrastim.

In October, Cinfa Biotech announced that EMA had accepted for review the company’s marketing authorization application for B12019.

As many hope that the arrival of a pegfilgrastim biosimilar will increase patient access, it will heavily depend on the cost of the drug, said Leora Horn, MD, clinical director of thoracic oncology at Vanderbilt-Ingraham Cancer Center, assistant vice chancellor for faculty development at Vanderbilt University Medical Center, in an interview with The American Journal of Managed Care®.

"You can sort of think of a biosimilar as a generic version of a chemo agent and if the cost of the drug is as high as some of the generic agents we have in the United States, it’s not going to make it any more affordable for our cancer patients," she said.