The U.S. Court of Appeals for the Federal Circuit granted a major victory for Novartis AG, the world’s pharmaceutical market leader. The court’s three-judge panel ruled 2-1 on Wednesday, declining a petition to renew a six-month injunction filed by competitor Amgen involving the marketing of a biosimilar drug comparable to Amgen’s breakthrough cancer treatment Neupogen
The U.S. Court of Appeals for the Federal Circuit granted a major victory for Novartis AG, the world’s pharmaceutical market leader. The court’s three-judge panel ruled 2-1 on Wednesday, declining a petition to renew a six-month injunction filed by competitor Amgen involving the marketing of a biosimilar drug comparable to Amgen’s breakthrough cancer treatment Neupogen. Novartis’s generic drug unit Sandoz was sued by Amgen last October after developing a copycat, although not identical, version of the drug, calling it Zarxio. Biosimilar drugs are not exact duplicates of a drug like generics are, but instead are close-copies of biologic products, made inside of living cells. The lifting of the injunction allows Sandoz to begin marketing Zarixo, the first biosimilar drug approved in the U.S., the world’s largest pharmaceutical market. Biosimilar drugs have been approved in Europe since 2006.
Despite the ruling, much work will need to be completed before Zarixo is sold commercially. Both sides await a rare en banc panel to debate petitions to rehear a compromise ruling made earlier this year involving the complicated Biologics Price Competition and Innovation Act (BPCIA). That ruling allowed biosimilar drugs to enter the marketplace after providing a six-month notice upon receiving approval from the Food and Drug Administration (FDA). Zarixo was approved by the FDA in March, with Wednesday ending the six-month moratorium. There is still ongoing patent-infringement litigation, however, that also needs to be resolved in the Northern District of California. Although Sandoz has the right to market the product following Wednesday’s ruling, doing so without a legal resolution in either case could open the company up to liability. Although the drug will not be sold for use in the near-term, Sandoz announced in court papers that it began marketing the drug on Thursday.
The approval of biosimilar drugs in the U.S. could lead to significant cost-savings. A Sandoz representative said that the Wholesale Acquisition Cost (WAC) for Zarixo would cost about 15 percent less than Neupogen. Some insurance companies claim that the biosimilar drugs could ultimately lead to savings of 40 percent or more. Several other biosimilar treatments are awaiting FDA approval, including another biosimilar version of Neupogen from drugmaker Apotex. As a testament to the high-stakes and complicated nature of the pharmaceutical industry, Novartis also announced on Tuesday that it has partnered with Amgen in the development of a breakthrough Alzheimer’s treatment called BACE inhibitors.
BioPharma Reporter – Dan Stanton
The Recorder – Diego Radzinschi
Reuters – Andrew Chung