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Pelmeg® is a biosimilar pegfilgrastim, which obtained European Union (EU) regulatory approval in September 2018, with marketing beginning in January 2019. A comprehensive analytical, functional and preclinical comparability programme demonstrated a high degree of similarity between Pelmeg® and its reference product Neulasta®. A targeted clinical development programme was conducted with Pelmeg®, consisting of two comparative pharmacokinetic (PK)/pharmacodynamic (PD) studies in healthy subjects. Since a surrogate endpoint for efficacy (absolute neutrophil count [ANC]) was available, efficacy and safety studies in patients were waived by the regulatory authorities. Clinical studies with Pelmeg® were designed in close dialogue with regulatory authorities in Europe. During the development process for Pelmeg®, the EU biosimilar guidelines, in particular relating to granulocyte colony-stimulating factor (G-CSF), were modified. The development of Pelmeg® demonstrates that regular discussions with regulators, in the form of scientific advice or other interactions, are valuable opportunities for dialogue regarding scientific progress related to the comparability of biosimilars. Regulators – at least in the area of biosimilar development – were found to be open to improvements and to deviate from existing guidelines if there was agreement that the scientific state-of-the-art has superseded some aspect of the guidelines. Overall, we suggest that abridged development programmes waiving the need for phase III studies, as described for Pelmeg®, are possible, in particular if good surrogate endpoints are available. In line with this, the number of waivers for phase III studies in biosimilar development has increased in recent years.

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