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EMEA: Concept paper on the development of a guideline on similar biological medicinal products containing monoclonal antibodies

19.11.2009
This guideline lays down the non-clinical and clinical requirements for monoclonal antibody-containing medicinal products claiming to be similar to another one already marketed, i.e. similar biological medicinal products (biosimilars).
The source of the news: http://www.emea.europa.eu/pdfs/human/biosimilar/63261309en.pdf