Once intellectual property protection, data and marketing exclusivity of reference medicines have expired, generic medicines and biosimilar medicines can enter the off-patent market.
Given that there tends to be confusion surrounding generic and biosimilar medicines, this Supplement describes some important aspects of these medicines. Simoens' Editorial introduces basic concepts related to generic and biosimilar medicines. Vogler et al. calculated the difference in ex-factory prices between five generic and reference medicines for 16 European countries, Godman et al. explored the contribution that low-priced generic medicines can make to enhance prescribing efficiency and support comprehensive and equitable health care, and Barei et al. showed that the switch from generic to biosimilar medicines appears to be driven by the lack of innovation in product portfolios, price pressure, competition and industrial evolution. At the same time, the development of biosimilar medicines is a source of innovation in itself as it requires the application of new technical, scientific, economic and commercial competencies. In this way, biosimilar medicines can provide a significant societal contribution by means of cost reduction and improved access to high-quality, innovative pharmacotherapy.
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