Neuraxpharm Vows Swift Appeal Over Pulled EU Tecfidera Generics

CNS Specialist Says Decision Was ‘Rooted In A Highly Disputed Legal Interpretation’

 
• By David Wallace
  
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Neuraxpharm has vowed to rapidly challenge a legal decision that has seen generic rivals to Biogen’s Tecfidera (dimethyl fumarate) multiple sclerosis treatment pulled from the market in Europe.

EU court of justice - Luxenbourg
Neuraxpharm says it will ‘swiftly contest’ the decision to pull generics from the market

Neuraxpharm has vowed to “swiftly contest” a decision that has pushed generic rivals to Biogen’s Tecfidera (dimethyl fumarate) out of the market in Europe, insisting that the removal of marketing authorizations for off-patent rivals is “rooted in a highly disputed legal interpretation” and “contradicts the European Medicines Agency’s own prior scientific review.”

Late last year, the European Commission revoked centralized marketing authorizations for generic dimethyl fumarate sold by Neuraxpharm as well as...

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