Tuesday, February 2nd, Teva Pharmaceuticals announced that the FDA will review its new biologic license application (BLA) to sell a biotechnology medicine, Neutroval, to boost white blood cells, which is “similar” to Amgen Inc’s Neupogen®(filgrastim). The new product is already marketed as TevaGrastim in Europe. There is a regulatory pathway for approving generic versions of biotech drugs in place in Europe. The US still does not have this option; therefore Teva treated this application like a new BLA.
The route to biosimilar approvals or generics for biologics is tied up in the U.S. Congress as part of the healthcare reform legislation, with no light at the end of the tunnel.