Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges

Waiving in vivo studies for monoclonal antibody biosimilar development: National and global challenges

Biosimilars are biological medicinal products that contain a version of the active substance of an already authorised original biological medicinal product (the innovator or reference product). The first approved biosimilar medicines were small proteins, and more recently biosimilar versions of inno...

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Bibliographic Details
Main Authors: Chapman, Kathryn, Adjei, Akosua, Baldrick, Paul, da Silva, Antonio, De Smet, Karen, DiCicco, Richard, Hong, Seung Suh, Jones, David, Leach, Michael W., McBlane, James, Ragan, Ian, Reddy, Praveen, Stewart, Donald I. H., Suitters, Amanda, Sims, Jennifer
Format: Online
Language:English
Published: Taylor & Francis 2016
Online Access:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4966840/

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4966840/

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