US Supreme Court Makes Landmark Decision in Biosimilar Notification Case


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-13-2017 15:04

  

In a landmark decision, the US Supreme Court ruled in favor of biosimilar developers regarding notification requirements by a biosimilar developer to an innovator drug company in a case between Sandoz, the generic drug arm of Novartis, and Amgen. The case involved 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 dealt 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 the180-day notification required under the BPCIA by the biosimilar developer to the innovator company follows FDA approval of the biosimilar. Sandoz was arguing that the notification should be able to occur earlier in the development process.

In its ruling, the US Supreme Court favored with Sandoz and reversed the decision of the federal appellate court. In its ruling, the US Supreme Court said that Sandoz had fully complied when it first gave notice (before licensure, i.e., FDA approval) in July 2014, and the court had erred in issuing a federal injunction prohibiting Sandoz from marketing Zarxio until 180 days after licensure. It also discounted measures by Amgen seeking state rellef on the notification issue because Amgen’s request for state-law relief was predicated on its argument that the BPCIA forbids prelicensure notice, so its claim under California’s unfair competition law also failed. 

Source: US Supreme Court

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