Banner Prepares to Launch Generic Novel Fumarate Bafiertam

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.

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

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