Module 9 2021

22/03/2021

CHANGES TO PRODUCT QUALITY ATTRIBUTES

Seokkyun Kim, Jinsu Song, Seungkyu Park, Sunyoung Ham, Kyungyeol Paek, Minjung Kang, Yunjung Chae, Heewon Seo, Hyung-Chan Kim & Michael Flores (2017): Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimi. mAbs, DOI: 10.1080/19420862.201 7.1305530 To link to this article: http://dx.doi.org/10.10 80/19420862.2017.130 5530

37

NON CLINICAL DATA REQUIREMENTS

38

19