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A Three-Arm, Tiered Comparability Strategy Bridging Post-Approval Process Changes for an Omalizumab Biosimilar (CMAB007).

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Title: A Three-Arm, Tiered Comparability Strategy Bridging Post-Approval Process Changes for an Omalizumab Biosimilar (CMAB007).
Authors: Wang, Chenguang1,2,3,4 (AUTHOR), Zhou, Chaoxin1,2,3,4 (AUTHOR), Hou, Sheng1,2,3,4 (AUTHOR), Fan, Wenqiang1,4 (AUTHOR), Qian, Weizhu1,2,3,4 (AUTHOR), Ren, Yule1,2,3,4 (AUTHOR), Chen, Xiyuan4 (AUTHOR), Pan, Chenhong4 (AUTHOR), Guo, Qingcheng1,2,3,4 (AUTHOR), Guo, Huaizu1,2,3 (AUTHOR), Guo, Yajun1,2,3 (AUTHOR)
Source: Pharmaceuticals (14248247). May2026, Vol. 19 Issue 5, p724. 17p.
Database: Academic Search Ultimate
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ISSN:14248247
DOI:10.3390/ph19050724