What is a biosimilar? How far does the similarity go? :Case study of G-CSF (filgrastim) [Qu'est-ce qu'un biosimilaire ? Jusqu'où va la similarité ? : étude de cas du G-CSF (filgrastim)]

摘要

Similar biological medicinal products, also called "biosimilars" or "follow-on biologics" are copies of originator biopharmaceutical products that have lost patent protection. To obtain regulatory approval for a biosimilar product, demonstration of comparability with an approved reference biopharmaceutical product in terms of quality, efficacy and tolerability is needed. To discuss the extent of this similarity, two recombinant human granulocyte colony-stimulating factor (GCSF) biosimilars approved in Europe will be used as examples. The published comparative results of the quality and clinical comparability of Zarzio? and Nivestim? to their reference product Neupogen? are reported and discussed in this article.