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Banner Beats Biogen On Tecfidera Technicality

Hybrid 505(b)(2) Product Holds Tentative US Approval

 
• By Dean Rudge

Having developed a novel bioequivalent alternative to Biogen's Tecfidera brand through the FDA's 505(b)(2) pathway, Banner Life Sciences has defended itself, with success, against claims that its product infringed a key method-of-use patent shielding the multi-billion-dollar multiple-sclerosis brand.

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A US Court Appeals has ruled in favor of Banner Life Sciences • Source: Shutterstock

A US Court of Appeals ruling has opened the door for Banner Life Sciences’ Bafiertam (monomethyl fumarate) delayed-release capsules, upholding a decision that the proposed product does not infringe “the extended portion” of a method-of-use patent shielding Biogen’s $3.3bn Tecfidera (dimethyl fumarate) brand.

In January this year, a Delaware district court ruled that Banner’s hybrid 505(b)(2) new drug application product, which currently holds...

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