The Supreme Court is seeking guidance from the Department of Justice in regards to a case between Amgen and Novartis’ generics unit, Sandoz. The point up for debate is whether Sandoz should be able to market their drug, Zarxio, which is a biosimilar version of Amgen’s Neulasta.
At the heart of the issue is a provision of the Biologics Price Competition and Innovation Act, which requires biosimilars companies to give 180 days’ notice to the makers of the branded version of the drug, prior to launching the product on the market. Sandoz says that they should be able to provide that notice before the US Food and Drug Administration (FDA) approves the drug.
Last year, an appeals court ruled in favour of Amgen, saying that the 180 days’ notice must be given after regulatory approval has been received. While a 6-month wait time may not seem too unreasonable, the time could allow the brand-name biologics maker to prepare further patent barriers to prevent the biosimilar from being launched. The wait time also affords the original drugmaker more time to sell their branded biologic.
While Sandoz’s Zarxio won FDA approval last year, the company has been tied-up in a legal battle ever since. After Sandoz appealed the initial court ruling, the case was pushed to the Supreme Court.
The Supreme Court has now asked the Solicitor General to express the view of the Obama administration on the matter, by filing a brief on biosimilars. According to the patent law firm Fish & Richardson, the Supreme Court’s invitation to the Department of Justice will likely set any ruling back by at least four months.
When a ruling is made, the decision will set the precedence for the growing biosimilars industry in the US. The FDA has so far only approved two biosimilars: Novartis’ Zarxio as well as Celltrion and Pfizer’s Inflectra.
A number of other drugmakers are awaiting the FDA’s decision on their biosimilar drugs. The Supreme Court ruling could have a major effect on the time to market for future biosimilars.