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Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to Herceptin (R) with a Panel of Sensitive and Orthogonal Methods Including a Novel Fc gamma RIIIa Affinity Chromatography Technology

Xie, LQ; Zhang, EH; Xu, YP; Gao, WY; Wang, LL; Xie, MHW; Qin, PL; Lu, LH; Li, SP; Shen, PC; Jiang, WD; Liu, S

Xie, MHW (corresponding author), Shanghai Henlius Biotech Inc, Shanghai Engn Res Ctr Antitumor Biol Drugs, Shanghai, Peoples R China.

BIODRUGS, 2020; 34 (3): 363

Abstract

Background A biosimilar needs to demonstrate its similarity to the originator reference product (RP) in terms of structural and functional properties ......

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