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Banner Beats Biogen On Tecfidera Technicality

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

Executive Summary

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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