RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

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


© 2022 Regulatory Affairs Professionals Society.