Jump to Main Content
- Arato, Teruyo, et al. Show all 2 Author
- Biologicals 2011 v.39 no.5 pp. 328-332
- European Union; World Health Organization; exercise; guidelines; Canada; Japan
- ... Recently, WHO, EU, Japan and Canada have published guidelines on biosimilar/follow-on biologics. While there seems to be no significant difference in the general concept in these guidelines, the data to be submitted for product approval are partially different. Differences have been noted in the requirements for comparability studies on stability, prerequisites for reference product, or for the ne ...