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Drug Industry Daily
June 19, 2012 | Vol. 11 No. 120
EMA Recommends Stepwise Approach for Developing Biosimilar Monoclonal Antibodies
Developers of biosimilar monoclonal antibodies (mAb) must conduct nonclinical and clinical studies that compare the biosimilars with the original monoclonal antibody to detect any relevant differences between the two products, according to a final European Medicines Agency (EMA) guideline released Friday.
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