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Challenges for Streamlining the Development of Biosimilars: A Japanese Perspective

Worldwide activity of the development of biosimilar products has increased since the first biosimilar product somatropin was approved in the European Union (EU) in 2005. The development strategies for biosimilars are almost the same in Japan and the European Union / United States (US); however, there are slight differences in regulatory frameworks among agencies. This paper explains these differences in biosimilar regulation between Japan and the European Union / United States and provides examples of strategies leading to efficient development of biosimilars.