Banner Beats Biogen On Tecfidera Technicality
Hybrid 505(b)(2) Product Holds Tentative US Approval
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.
