Biosimilar Products

Guideline for the quality, safety and efficacy of follow-on biological medicinal products issued by Ministry of Health, Labour and Welfare, Govermment of Japan

The translation provided here for the MHLW’s notification on biosimilar products is interim translation by JGA. If any discrepancy arises between the Japanese original and the interim translation, the former is authentic.

  1. Interim Translation
  2. Original in Japanese

Questions and Answers (Q&A) regarding the Guideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics

  1. MHLW issued in July, 2009
  2. MHLW issued in March, 2010
  3. MHLW issued in Dec, 2015