New EU Rule Eases Biosimilar Development
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...
To view the full article, register now.