Abstract
The term “generic” applies to products containing mostly small-molecule chemical active substances, usually produced by chemical synthesis. EU legislation describes a generic product as a product which has the same active substance in the same amount as the originator’s product (the reference product) and the same pharmaceutical form and whose bioequivalence with the reference product has been demonstrated by appropriate bioavailability studies [1]. “Innovative” products in most countries of the world are rewarded and protected from competition in a number of ways, but they are not allowed to keep the market to themselves indefinitely. Generic medicines are basically copies of these innovative medicines which have been marketed for several years with proven efficacy and safety. The passage of time (10 years in most EU Member States) transforms innovative medicines with new active substances into established medicines and opens the door to generic competition.
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References
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Deforce, D., Wade, G., Bloechl-Daum, B. (2016). Generics, Biosimilars, Enantiomers, and Me-Toos. In: Müller, M. (eds) Clinical Pharmacology: Current Topics and Case Studies. Springer, Cham. https://doi.org/10.1007/978-3-319-27347-1_20
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DOI: https://doi.org/10.1007/978-3-319-27347-1_20
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