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More positive phase I results for Coherus pegfilgrastim biosimilar Posted 16/09/2016

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 11 July 2016 that follow-on results from a phase I study of its candidate pegfilgrastim biosimilar (CHS 1701) were positive.

The aims of the phase I trial were to study the pharmacokinetics (PK), pharmacodynamics (PD) and safety (including immunogenicity) of a single 6 mg subcutaneous injection of Coherus’s biosimilar (CHS-1701) compared to Amgen’s neutropenia* treatment Neulasta (pegfilgrastim). The trial was a randomized, single-blind, three-sequence, three-period crossover study in healthy patients. It was carried out as a follow-up to the previous study, CHS-1701-03. Subject inclusion criteria, procedures and study design, as well as other measures were designed to decrease subject variability and eliminate the extreme subject outliers previously observed.

A total of 122 healthy subjects were randomized to one of three treatment sequences and received three 6 mg subcutaneous injections (a single dose in each period) of either CHS-1701 or Neulasta in a random order.

The study met all of its co-primary endpoints for PK: Cmax and area under the curve (AUC), and for PD: absolute neutrophil count, and ANC (ANCmax and ANC AUC). For both endpoints, the 90% confidence intervals (CI) for the geometric mean ratio (GMR) were well-contained within the pre-specified margins of 80% to 125%.

The safety profiles of CHS-1701 and Neulasta were also ‘very similar’, according to Coherus. There were no serious adverse events related to either study drug or clinical meaningful difference between CHS-1701 or Neulasta leading to study drug discontinuations.

This study was completed in June 2016 and another phase I study of the candidate pegfilgrastim biosimilar (CHS 1701) was finished in July 2015 [1]. A third phase I study of the immunogenicity of CHS-1701 compared to Neulasta was planned to be completed in December 2015, according to ClinicalTrials.gov. Coherus is also working on bevacizumab and ranibizumab candidate biosimilars, ‘as well as other product candidates’.

According to Mr Dennis Lanfear, CEO of Coherus, these latest results support the company’s plans to file for approval of its pegfilgrastim biosimilar in the third quarter of 2016.

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

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sept 16]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-results-for-pegfilgrastim-biosimilar

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Source: ClinicalTrials.gov, Coherus

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