The aims of the phase I trial, which was carried out in Germany, were to study the immunogenicity and pharmacodynamic (PD) comparability of Cinfa’s biosimilar (B12019) compared to Amgen’s neutropenia* treatment Neulasta (pegfilgrastim). The trial is a randomized, double-blind, multiple-dose, 3-period, 2-sequence, crossover study in healthy patients.

A total of 96 healthy volunteer subjects were randomized to one of two treatment sequences and received two single doses of either B12019 or Neulasta followed by a single dose of either Neulasta or B12019, respectively.

According to Cinfa, ‘the study met its primary endpoints: area under the effect curve (AUEC_0-last) for PD and anti-drug antibody rate (ADA) for immunogenicity, confirming comparability to Neulasta’. The company also said that ‘all secondary endpoints were achieved’, although it did not specify what these were. In addition, Cinfa added that ‘the safety of B12019 was also comparable to Neulasta’.

This is the second phase I trial carried out by Cinfa for its pegfilgrastim biosimilar. The company has also carried out a multicentre, double-blind, randomized, 2-way cross-over study to investigate the pharmacokinetic and PD of B12019 as compared to Neulasta administered as a single subcutaneous dose in healthy male subjects.

Given the positive results, Cinfa believes that it is on track to file for approval of its pegfilgrastim biosimilar in the second half of 2017.

_{*Neutropenia is a lack of certain white blood cells caused by cancer chemotherapy}

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