Teva Pharmaceutical Industries has officially become a thorn in Amgen's side. The Israeli generics giant has asked FDA to approve its biotech drug designed to increase white blood cells in cancer patients--designed to be biosimilar to Amgen's $1 billion-plus Neupogen. Though it's certainly not the first time Teva has taken aim at a branded drug in the U.S., it's the first time Amgen has faced a potential generic rival for its high-tech medicines here.
Teva's XM02 is already sold under the TevaGrastim brand in Europe, which has a framework for approval of generic biotech drugs, or biosimilars. It has lawyered up for the Amgen fight, suing the California-based company to pre-empt any patent infringement claims. Teva is asking the court to rule that its new med won't violate Amgen's patent rights.
But first, Teva will have to get FDA approval, and because it's asking the agency for its blessing before biosimilars legislation has passed in the U.S., the XM02 app is technically for a new drug. The Neupogen copy was the first biosimilar of its kind approved in Europe, Teva says: "[W]e look forward to working closely with the FDA to bring this important treatment option to the U.S." Now Amgen knows how so much of Big Pharma feels.