Challenges for Streamlining the Development of Biosimilars: A Japanese Perspective

Abstract

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. DEVELOPMENT STRATEGY OF BIOSIMILAR PRODUCTS

Advancing Innovations in Biosimilars

“…Other articles focus on characterizing the relationship between product quality characteristics (e.g., structural and functional characterization) and clinical performance to further streamline clinical development 7–9 . Global alignment of regulatory expectations for biosimilar approval makes biosimilar development more efficient and attractive to sponsors, and we are happy to see articles in this issue from regions around the world; in addition to the United States, this includes articles with viewpoints from Canada, 10 Europe, 7 India, 11 and Japan 12 . Finally, other articles focus on the importance of educating clinicians and patients about biosimilars and assessing the cost to patients.…”

“…discuss evidentiary considerations with practical examples to illustrate the thinking behind the recommendations in the FDA's guidance. Arato 12 and Wang 10 discuss perspectives from Japan and Canada, respectively.…”

“…To this end, Strauss et al 1 discuss evidentiary considerations with practical examples to illustrate the thinking behind the recommendations in the FDA's guidance. Arato 12 and Wang 10 discuss perspectives from Japan and Canada, respectively. European Public Assessment Report website 19 Health Canada website 20 Paper by Arato 11 , PMDA website 21 PMDA, Pharmaceuticals and Medical Devices Agency.…”

“…[7][8][9] Global alignment of regulatory expectations for biosimilar approval makes biosimilar development more efficient and attractive to sponsors, and we are happy to see articles in this issue from regions around the world; in addition to the United States, this includes articles with viewpoints from Canada, 10 Europe, 7 India, 11 and Japan. 12 Finally, other articles focus on the importance of educating clinicians and patients about biosimilars and assessing the cost to patients. All of this is summarized further below.…”