Biosimilars In EU: From 'New Mess' To Beacon For Safety

Finnish Medicines Agency's Ekman says neither regulators nor industry knew what to do when the biosimilars regulatory framework was first introduced, but there haven't been any differences in adverse events between biosimilars and their reference products.

airport runway under the sun as background

When the biosimilar regulatory framework was first introduced in the European Union (EU) in 2004, the whole thing was a "new mess," says Finnish Medicines Agency senior researcher Niklas Ekman.

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