US Supreme Court to decide on biosimilar waiting period

16 January 2017

The United States Supreme Court has agreed to hear a case that will determine whether companies that develop biosimilar versions of biologics must wait six months before launching them in the US.

Swiss drug giant Novartis (NOVN: VX) is appealing a 2015 federal appeals court verdict that blocked it from selling its biosimilar version of the $1-billion-a-year hematology product Neupogen (filgrastim), sold by California-based Amgen (Nasdaq: AMGN).

Novartis claims that the additional six-month waiting period is unwarranted, given that Amgen had already enjoyed 12 years of exclusivity under patent law.

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