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How similar do 'biosimilars' need to be?

Nature Biotechnology volume 22, pages 1357–1359 (2004)Cite this article

A fierce debate is currently underway concerning the requirements for a marketing authorization for 'biosimilars'—an alternative term for 'biogenerics' recently formally introduced into the drug development lexicon in two guidelines from the European Medicine Agency's (EMEA; London) Committee for Proprietary Medicinal Products (CPMP)1,2. Unlike small molecules, protein drugs are not produced by chemical syntheses but by cells in culture or whole organisms, which are inherently more variable. The assessment of the 'bioequivalence' of a protein produced by two different manufacturers thus presents a much greater challenge to regulators. The R&D industry claims that patient safety demands clinical and safety studies for every indication claimed; the generics industry counters that simple comparisons of bioequivalence on the basis of surrogate markers for clinical efficacy is adequate. Although the EMEA guidances now provide a rigorous assessment of the quality, safety and efficacy requirements for biosimilar products, several outstanding issues will likely hamper entry of generics companies into this market (Box 1).

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References

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  1. Central Laboratory Animal Institute and Department of Innovation Studies, Utrecht University, Bolognalaan 50, Utrecht, 3584 CJ, The Netherlands

    Huub Schellekens

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  1. Huub Schellekens
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Schellekens, H. How similar do 'biosimilars' need to be?. Nat Biotechnol 22, 1357–1359 (2004). https://doi.org/10.1038/nbt1104-1357

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