We use cookies on this site to enable your digital experience. By continuing to use this site, you are agreeing to our cookie policy. close

E.U. Trumps FDA In Approval Of Biologics

Law360 (February 1, 2006, 12:00 AM EST) -- In a sign the United States and the European Union will soon be on different playing fields when it comes to generic biotechnology drugs, the European Commission has moved to grant Sandoz GmbH authority to sell human growth hormone Omnitrope, the first approved “biologic.”

The European Medicines Agency (EMEA) said biologics may now be authorized on the basis of appropriate non-clinical and clinical data requirements. That’s the same basis for approval Sandoz has sought in the United States, using provision 505(b) of the 1984 Hatch Waxman...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.