New EU Rule Eases Biosimilar Development

Law360, New York (November 29, 2010, 4:46 PM EST) -- The European Medicines Agency has published draft guidelines on biosimilars with monoclonal antibodies, loosening some restrictions on development of the drugs, which are used to treat cancer and autoimmune diseases.


The guidelines, published on Nov. 23, recommended a case-by-case evaluation of monoclonal antibody drugs in non-clinical development, with in-vitro studies receiving preference over in-vivo studies. If in-vivo studies were necessary, the guideline said, researchers should avoid conducting toxicological studies on non-human primates.


A three-step risk-based approach should govern non-clinical studies, the EMA said, emphasizing...
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