EMEA Issues Guidance On Biosimilar Drugs

Law360, New York (July 16, 2007, 12:00 AM EDT) -- In a move that is likely to spark debate on both sides of the Atlantic, the European Medical Agency has issued new guidelines on the approval and regulation of biosimilar medicines, stating that they should not be treated like generic drugs.

The guidelines, titled “Questions and Answers on Biosimilar Medicines” and published on Monday, clarifies the process by which biosimilar treatments—medicines that are derived from a living organism—are approved and regulated.

In the document, the EMEA states that “due to the differences stemming from the variability...
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