The FDA has delayed its decision on Teva Pharmaceutical's Neutroval, a biosimilar copay of Amgen Neupogen for neutropenia in cancer patients. The good news for Teva is that the agency doesn't want additional trials for the drug. Regulators just want additional information on Neutroval, though the company declined to say what exactly the agency asked for.
Neutroval is already sold in Europe, where guidelines for approving generic biologic drugs have been in place for some time. In March U.S. lawmakers passed legislation supporting a biosimilar pathway, but FDA has not yet issued guidance for biosimilar approval. Teva submitted its Neutroval application before that legislation is was passed, forcing the generic drugmaker to go through regular FDA approval process.
Neupogen is a blockbuster drug for Amgen; Teva's branded generic will likely be the first biosimilar challenge the biotech faces. Amgen has already filed a patent-infringement and is expected to block Neutroval's launch once it's approved.
- read the WSJ report