FDA: Novartis Arthritis Drug 'Highly Similar' to Amgen's Enbrel

Jul 12, 2016

Novartis AG’s version of the arthritis drug Enbrel is comparable to the original made by Amgen Inc., according to the U.S. Food and Drug Administration.

FDA staff called the injection from Novartis “highly similar” to Enbrel, reports Bloomberg. The injection is used to treat five chronic inflammatory conditions, including rheumatoid arthritis and plaque psoriasis.

Reuters reports Enbrel, which was approved in 1998, generated more than $5 billion in U.S. sales last year. Novartis, through its generic drug division Sandoz, is seeking U.S. approval.

The FDA review found there were no clinically meaningful differences between the two drugs in the studied condition of psoriasis.

Read the full report from Reuters here, or the full report from Bloomberg here. 

Show Comments
Hide Comments

Join the discussion

We welcome your thoughtful comments.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments