A recent court decision put Mylan N.V. in the spotlight for its win over Biogen concerning the patent of the latter’s best-selling multiple sclerosis (MS) therapy Tecfidera (dimethyl fumarate). The decision to invalidate the patent paves the way for Mylan to launch a generic of the drug this fall, assuming the FDA approves it. But seemingly under the radar is another manufacturer’s announcement that it would launch a generic novel fumarate next month, possibly making it the first on the U.S. market.
The FDA approved Banner Life Sciences LLC’s Bafiertam (monomethyl fumarate) on April 28 for the treatment of adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. The drug was approved through a new drug application under the 505(b)(2) pathway, with Tecfidera as the reference drug.