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

Executive Summary

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.

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EU Officials Note Similarities In Post-Approval Changes For Biosimilars, Reference Drugs

EU pharmaceutical and industry officials note some common trends and similarities in post-approval changes for biosimilars and reference products. One vexing problem in instituting post-approval changes is whether to use the reference drug or the approved biosimilar and regulatory guidance in this area is lacking.

EU Officials Note Similarities In Post-Approval Changes For Biosimilars, Reference Drugs

EU pharmaceutical and industry officials note some common trends and similarities in post-approval changes for biosimilars and reference products. One vexing problem in instituting post-approval changes is whether to use the reference drug or the approved biosimilar and regulatory guidance in this area is lacking.

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