EMA 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 biosimilar medicines, 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.
Stakeholders are invited to send their comments on the reflection paper via an online EUSurvey until 30 September 2025.
A biosimilar is a biological medicine that is highly similar to another already approved biological medicine (the ‘reference medicine’). Biosimilar medicines have become important therapeutic options improving patient access to essential treatments. They are used to treat a variety of diseases such as cancer, rheumatoid arthritis and inflammatory bowel disease. They offer the same clinical effectiveness and safety as their reference product. By providing competition in the market, they can expand patient access to critical medicines…
