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Regulatory considerations in oncologic biosimilar drug development

Biosimilar monoclonal antibodies are being developed globally for patients with different types of solid tumors and hematologic malignancies. Applications for proposed biosimilar monoclonal antibodies are being submitted to the regulatory authorities around the world and may increase patient access...

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Shranjeno v:
Bibliografske podrobnosti
izdano v:MAbs
Main Authors: Macdonald, Judith C, Hartman, Helen, Jacobs, Ira A
Format: Artigo
Jezik:Inglês
Izdano: Taylor & Francis 2015
Teme:
Online dostop:https://ncbi.nlm.nih.gov/pmc/articles/PMC4622730/
https://ncbi.nlm.nih.gov/pubmed/25961747
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1080/19420862.2015.1040973
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