Hexal Sues EMA Over Refusal To Accept Generic Aubagio Filing

Hexal is challenging a decision by the European Medicines Agency to reject its application for a generic version of Sanofi’s MS drug Aubagio, raising fresh questions about how a new active substance is defined. By contrast, a generic version from Glenmark was recently approved in the US.

PhoneScales — Hexal is taking the EMA to court over generic teriflunomide • Source: Shutterstock

Germany’s Hexal AG is taking the European Medicines Agency to court over its refusal to accept a marketing authorization application (MAA) for its generic version of Sanofi’s multiple sclerosis (MS) drug Aubagio (teriflunomide).

According to Hexal (part of Sandoz), the EMA was wrong to decide in 2013 that teriflunomide was a new active...