EMA Finalises Guidance on Medicines Containing Monoclonal Antibodies
The EMA has finalised two documents providing pharmaceutical companies with guidance on how to develop medicines containing monoclonal antibodies.
The European Medicines Agency has finalised two documents providing pharmaceutical companies with guidance on how to develop medicines containing monoclonal antibodies.
The guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical aspects provides information on the requirements for companies developing medicines containing monoclonal antibodies that are similar to medicines already authorised.
The guidance contains answers to questions frequently asked by companies with an interest in developing similar biological (biosimilar) monoclonal antibodies. It lays out a stepwise approach for the development programme, covering the testing these medicines in in-vitro studies and in animal studies, if needed, as well as testing in hum
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