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Regulatory Focus™ > News Articles > Follow-on Biologics in the EU & US

Follow-on Biologics in the EU & US

Posted 01 January 2008

Global regulatory agencies are working hard to facilitate bringing copies of well-known medicinal biologics to market. Three key factors drive this process:

  • technological advancements permitting better characterization and testing of protein-based biologic products
  • patent expiration on many biologics in the EU and US
  • escalating healthcare costs

 

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