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Biosimilars versus generics: scientific basics and clinical implications

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Abstract

Generic drugs contain the identical chemical copy of their cognate originator drug’s active ingredient and this can be proven by their physicochemical properties and the structural identity. A more complex situation is given when it comes to biological drugs, where identical copies cannot be produced. Hence, similar to the approval of the originator biological drug, great care must be employed when approving biosimilar protein drugs. Furthermore, this needs to be continued after the entrance of biological/biosmilar drugs into the market: rigorous pharmacovigilance during their application is the key and the close surveillance of their production is mandatory. In this review, we will highlight the differences between generic and biosimilar drugs and point out what healthcare professionals need to know.

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Conflict of interest

Harald H. Sitte has received honoraria for lectures and consulting from Astra-Zeneca, Lundbeck, Nycomed, Roche, Sanofi-Aventis, Serumwerk Bernburg, TEVA/Ratiopharm and Torrex-Ciesi Pharma. Michael Freissmuth has received honoraria for lectures and consulting and research grants from Amgen, the Association of Austrian Sickness Funds, AOP Pharma, Astra Zeneca, Astropharma, Baxter, Cellgene, ratiopharm, Sandoz.

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  1. Center for Physiology and Pharmacology, Institute of Pharmacology, Medical University Vienna, Waehringerstrasse 13, 1090, Vienna, Austria

    Harald H. Sitte MD & Michael Freissmuth

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  1. Harald H. Sitte MD
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  2. Michael Freissmuth
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Correspondence to Harald H. Sitte MD.

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Sitte, H., Freissmuth, M. Biosimilars versus generics: scientific basics and clinical implications. memo 6, 202–206 (2013). https://doi.org/10.1007/s12254-013-0094-8

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  • DOI: https://doi.org/10.1007/s12254-013-0094-8

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