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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

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