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Apr 27, 2015

Approval of the First Biosimilar Monoclonal Antibody in Brazil

Today's approval is the first granted by ANVISA for a biosimilar monoclonal antibody. Celltrion's approval followed the abbreviated pathway as set forth in ANVISA's Rule #55/2010, which does not use the terms "biosimilar" or "biogeneric", but instead refers to a "new biologic product" for an innovator product and a "biologic product" for a biosimilar.
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