Pelmeg®, a biosimilar pegfilgrastim developed in the context of evolving regulatory guidelines

Category: Review Article
Author(s): , , , ,
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Keywords: biosimilar, filgrastim, Neulasta®, oncology, Pelmeg®

Pelmeg® is a biosimilar pegfilgrastim, which obtained EU regulatory approval in September 2018, with marketing starting in January 2019. A comprehensive analytical, functional, and preclinical comparability program demonstrated a high degree of similarity between Pelmeg® and its reference product Neulasta®. A targeted clinical development program was conducted with Pelmeg®, consisting of two comparative pharmacokinetic (PK)/pharmacodynamic (PD) studies in healthy subjects. Since a surrogate endpoint for efficacy (i.e. absolute neutrophil count [ANC]) was available, efficacy and safety studies in patients were waived by the regulatory authorities. The clinical studies with Pelmeg® were designed in close dialogue with regulatory authorities in Europe. During the development process for Pelmeg®, the biosimilar guidelines, in particular the granulocyte-colony stimulating factor (G-CSF) guideline, were modified. As experienced and shown by the Pelmeg® development program, scientific discussion with regulators in form of scientific advice or other interactions are valuable opportunities to stay in touch and in dialogue about the scientific progress and state of the art with regard to comparability of biosimilars. Regulators – at least in the evolving area of biosimilar development – were found to be open to improvements and to deviate even from existing guidelines if there is agreement that the scientific state-of-the-art has superseded some aspects of any of those guidelines. Overall, targeted/abridged development programs waiving the need for Phase 3 studies like the one described for Pelmeg® are possible, in particular if good surrogate endpoints are available. In line with this, the number of waivers for Phase 3 studies in biosimilar development has increased over the past years.

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