Current Issue

View Larger Image

Past Issues Free Subscriptions
Sponsored
Keywords



GEN Poll

 More »
Sep 10, 2012

Biosimilars for the U.S.

Do you think the FDA is taking too long in establishing final regulations for the approval of biosimilars in the U.S.?

Yes
 
  76.7%
No
 
  23.3%

Suggest a Poll
More Polls » View Results »

A biosimilar, as the name indicates, is similar to another biologic that has already been approved for use. In 2006, Sandoz received the first approval in the European Union for a biosimilar, Omnitrope®, a version of somatropin, or human growth hormone. The company subsequently received EU approval for a second biosimilar, Binocrit®, which is a version of epoetin alfa for regulating the formation of red blood cells. While Europe already has established a regulatory pathway for biosimilars, the U.S. remains engaged in discussions on draft guidance documents, definitions of study requirements, and intellectual property issues. Some industry analysts say that biosimilars can cost 20–25% less than the original product.

Related Content

GEN News Highlights

MORE RELATED GEN NEWS HIGHLIGHTS

Insight & Intelligence™

MORE RELATED INSIGHT & INTELLIGENCE™

GEN Articles

MORE RELATED GEN ARTICLES

GEN Webinars

View »

GEN Web Briefs

View »

GEN Poll

More » Poll Results » Archive »

GEN’s Hall of Shame

Will you be voting for any of the candidates on GEN’s Hall of Shame list in the next election?

Suggest a Poll