Abstract
In 2015, JFDA approved its biosimilars registration guidelines [1] officially. Many steps have been taken before achieving this progress. This paper summarizes briefly JFDA efforts that were done in the previous years and the actions taken to approve JFDA biosimilars registration guidance which was based on EMA related guidelines [2-5], and its impact on enhancing the affordability of safe, effective and high quality biosimilars for patients.
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