Mylan Launches Copy of Biogen’s Tecfidera After FDA Approval

Mylan NV said it has begun selling a generic version of Biogen Inc.’s blockbuster multiple sclerosis drug Tecfidera after obtaining U.S. regulatory approval this week.

The Food and Drug Administration approved Mylan’s application to sell dimethyl fumarate, the active ingredient in Tecfidera, on Monday, according to information posted on the agency’s registry of data on approved drugs. The agency was able to act after a federal judge in West Virginia invalidated the lone patent on the drug. Biogen is challenging that ruling, and an appeals court last month said it wouldn’t prevent Mylan from entering the market during the ...