Biogen Gets Temporary Halt On Unapproved Mylan MS Drug

Law360 (June 30, 2020, 9:38 PM EDT) -- Biogen has urged the Federal Circuit to bar Mylan from moving forward with a generic version of Biogen's top-selling multiple sclerosis drug Tecfidera while it appeals a patent invalidation, leading the appellate court to grant temporary relief Tuesday.

The Federal Circuit issued an interim injunction that would block Mylan Pharmaceuticals Inc. from going to market until the court can decide whether a longer injunction is necessary. However, the U.S. Food and Drug Administration has yet to approve Mylan's generic version, so it's unclear when the drug would be market ready.

Mylan has asked for an accelerated approval from the FDA, hoping...

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