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Biosimilar rhG-CSFs: how similar are they?

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Abstract

Biosimilars are more affordable copycat versions of originator biological products in much the same way as generics are copies of small molecule pharmaceuticals. However, while generics are approved on the basis of structural and pharmacokinetic equivalence, the intricate structure of biological medicinal products and the complex nature of their manufacturing process in living organisms impose a separate, and more stringent, regulatory approval process. The aims of this article are (a) to discuss key aspects of the development process and authorization requirements for biosimilars in Europe using published comparative physicochemical and clinical data for EU-approved recombinant human granulocyte colony stimulating factor (rhG-CSF) biosimilars, the most recent addition to the therapeutic category of hematopoietic growth factors, and (b) to demonstrate that the rigorous scientific evaluation process is designed to ensure that their clinical safety and efficacy is not compromised by the abbreviated development program.

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Notes

  1. The term “Biosimilar” refers to a similar biological medicinal product approved in the EU under specific legislation (see explanatory text later in this article). In this article, the term is used exclusively to describe medicinal products approved under the EU biosimilar pathway.

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Conflict of interest statement

No funds were received related to the subject of this manuscript. The authors have worked as consultants for companies developing biosimilars.

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  1. Triskel Integrated Services SA, 4 rue des Terreaux-du-Temple, 1201, Geneva, Switzerland

    Patricia Gravel, Aarti Naik & Jean-Yves Le Cotonnec

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  1. Patricia Gravel
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  2. Aarti Naik
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  3. Jean-Yves Le Cotonnec
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Correspondence to Aarti Naik.

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This article is adapted in English from the original Gravel P et al. (2011) Qu’est-ce qu’un biosimilaire ? Jusqu’où va la similarité ? Etude de cas du GCSF (filgrastim). Oncologie 13(5):183–190

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Gravel, P., Naik, A. & Le Cotonnec, JY. Biosimilar rhG-CSFs: how similar are they?. Targ Oncol 7 (Suppl 1), 3–16 (2012). https://doi.org/10.1007/s11523-011-0187-4

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