Since the first biosimilar product was approved in Europe in 2006, there have been many developments in the global regulatory environment, and the healthcare community’s understanding and acceptance of biosimilars. However, there are still a number of challenges in developing, registering, and marketing biosimilar medicines, with the ultimate objective always being to increase competition, drive down costs, and increase access to biologic medicines. This article examines progress to date in the establishment of the biosimilar market, challenges in bringing biosimilars to patients, the impact biosimilars have had, and potential future trends.
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