약학회지
YAKHAK HOEJI
ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)

Table. 7.

Table. 7.

The status of biosimilar policy by country

Country Date(year) Contents of biosimilar policy
EU 2005 CHMP/437/04 guideline on biosimilar
2010 Guideline on similar biological medicinal products containing monoclonal antibody
USA 2012 Guidance on biosimilar
China - No separate biosimilar guideline, Follow the biopharmaceutical regulations
Japan 2009 Guide for quality, safety and efficacy of biosimilar
India 2012 Guideline on biosimilar
Singapore 2010 Guidance on pharmaceutical registration, Appendix 17

Yakhak Hoeji 2021;65:1-9 https://doi.org/10.17480/psk.2021.65.1.1
© 2021 Yakhak Hoeji