Banner Life Sciences LLC says full approval of its drug Bafiertam for treating relapsing forms of multiple sclerosis is expected no later than June 20, 2020, following the expiration of a patent covering Biogen Inc.'s blockbuster drug Tecfidera.
Banner said Jan. 2 it received tentative approval for its new drug application in a letter in mid-November. Bafiertam is not a generic version of Tecfidera. Bafiertam is a novel fumarate bioequivalent alternative to Tecfidera (dimethyl fumarate).
Tecfidera has been a huge revenue-producer for Biogen, racking up U.S. sales of $1.55 billion in the first six months of 2018.
Banner’s drug will ...
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