EMA streamlining development and assessment of biosimilar medicines
The European Medicines Agency (EMA) announced it is exploring improvements to the development and evaluation of biosimilar medicines, while upholding strict European Union (EU) safety standards.
With over two decades of experience in evaluating biosimilars, the EMA anticipates that this approach will improve access to biosimilars for patients in the EU and ensure that Europe is an attractive market to develop these treatments.
The approach, which is outlined in a new draft reflection paper, would potentially reduce the amount of clinical data required for the development and approval of biosimilar medicines.
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