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Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to Herceptin(®) with a Panel of Sensitive and Orthogonal Methods Including a Novel FcγRIIIa Affinity Chromatography Technology
BACKGROUND: A biosimilar needs to demonstrate its similarity to the originator reference product (RP) in terms of structural and functional properties as well as nonclinical and clinical outcomes. OBJECTIVES: The aim was to assess the analytical similarity between the trastuzumab biosimilar HLX02 an...
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| Published in: | BioDrugs |
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| Main Authors: | , , , , , , , , , , , |
| Format: | Artigo |
| Language: | Inglês |
| Published: |
Springer International Publishing
2020
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| Subjects: | |
| Online Access: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7211197/ https://ncbi.nlm.nih.gov/pubmed/32072477 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40259-020-00407-0 |
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