In early March 2015, the Food and Drug Administration (“FDA”) approved Zarxio, the first “biosimilar” drug, to be introduced into the U.S. market. Biosimilars are expected to offer cheaper versions of existing biologics. They are nearly identical to the originals, and are used to treat the same conditions. Biosimilar drugs are expected to create a more competitive market by providing people with comparable, less expensive prescription medication.
Zarxio, the first of what is likely to be many biosimilar drugs to receive FDA approval, will compete with Neupogen, a drug prescribed to chemotherapy patients. Zarxio promises to be cheaper than Neupogen and similar enough to serve all five of Neupogen’s current uses. However, questions remain as to how effective biosimilars will be in lowering the cost of drugs. In fact, the makers of Zarxio have not announced how much cheaper the drug will be. Secondly, there is no telling whether clinicians will embrace biosimilars.
Amgen, the makers of Neupogen, asked a California federal judge for an injunction blocking the launch of Zarxio. They allege that the makers of Zarxio failed to follow the rules in seeking regulatory approval. A court hearing is set for March 13, and Novartis, the maker of Zarxio, has agreed not to sell Zarxio until the hearing or April 10, whichever is earlier.