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The constrained prescription, interchangeability and substitution of biosimilars

Nature Biotechnology volume 33, pages 688–689 (2015)Cite this article

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To the Editor:

The requirement for a marketing authorization of a biosimilar medicinal product in Europe includes demonstration of its similar nature to the originator product in terms of quality, efficacy and safety1. Biosimilarity is demonstrated through in-depth comparison of physical, chemical and in vitro biological characteristics and comparative nonclinical and clinical studies, which together are named the 'comparability exercise'2,3.

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Authors and Affiliations

  1. Paola Minghetti and Paolo Rocco are in the Department of Pharmaceutical Sciences, Università degli Studi di Milano, Milan, Italy.,

    Paola Minghetti & Paolo Rocco

  2. Huub Schellekens is in the Department of Pharmaceutical Sciences and Department of Innovation Studies, Utrecht University, Utrecht, the Netherlands.,

    Huub Schellekens

Authors
  1. Paola Minghetti
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  2. Paolo Rocco
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  3. Huub Schellekens
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Correspondence to Paola Minghetti.

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Competing interests

P.M. collaborated with Stallergenes, Genzyme, Vitalair, IBA and many other firms for continuing medical education (CME) programs. H.S. has a grant form Sandoz for characterization of biosimilars/bioquestionables and is a member of the ad board for Pfizer, Sanofi and Merck Serono.

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Minghetti, P., Rocco, P. & Schellekens, H. The constrained prescription, interchangeability and substitution of biosimilars. Nat Biotechnol 33, 688–689 (2015). https://doi.org/10.1038/nbt.3272

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