Skip to NavigationSkip to content

FDA greenlights Glenmark's generic version of Biogen's Tecfidera in relapsing multiple sclerosis

Published on 07/10/20 at 12:22pm

Glenmark Pharma will be celebrating after it secured FDA approval in the US to market dimethyl fumarate, a generic version of Biogen’s Tecfidera, for the treatment of relapsing multiple sclerosis in adult patients.  

Like it’s reference product, the approval is for a delayed-release formulation of the therapy in 120mg and 240mg doses.

The decision could be a significant boon to the company’s finances; according to 12-month IQVIA sales data leading up to the end of August this year, Tecfidera delayed-release capsules generated $3.8 billion in annual sales.

With this decision, Glenmark’s portfolio now spans 164 US-approved products, while a further 46 applications are awaiting review with the FDA. The company said it was committed to supporting the growth of this portfolio through external development partnerships.

Matt Fellows

Mission Statement is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches