The US Supreme Court heard oral arguments concerning notification requirements by a biosimilar developer to an innovator drug company in a case between Sandoz, the generic drug arm of Novartis, and Amgen that has implications for biosimilar launches in the US. The dispute involves the interpretation of the 180-day exclusivity period under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) for when biosimilars developers should notify the maker of the originator biologic that they intend to market a biosimilar. The timing of the notice impacts the 180-day exclusivity period for the originator product and the timing of commercial launch of the biosimilar.

The case deals with Sandoz’s Zarxio (filgrastim-sndz), which was approved in March 2015 by the US Food and Drug Administration (FDA) and a biosimilar that references Amgen’s Neupogen (fligrastim), a drug for treating neutropenia (low white blood cell count). A federal appeals court had ruled that a 180-day notification required under the BPCIA by the biosimilar developer to the innovator company follows FDA approval of the biosimilar. Sandoz is arguing that the notification should be able to occur earlier in the development process.

In the US Supreme Court hearing, the Justices questioned Sandoz and Amgen’s lawyers on several aspects of the BPCIA: the length of time it takes to gain FDA approval; a clearer explanation of what the term “notice” means; how the sponsor of the reference product would know specifics of a biosimilar application without the biosimilar applicant providing the application; and how a biosimilars developer can provide notice of an intent to market a biosimilar if the company doesn’t know for what the biosimilar is licensed. A decision from the US Supreme Court is not expected until later this year.

Source: US Supreme Court