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.
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Mylan was shot down in February this year by the USPTO after challenging Biogen’s key US patent 8,399,514 protecting Tecfidera. However, the ANDA sponsor has been backed by Bernstein to prevail in separate district court proceedings, clearing a path to potential market entry years earlier than otherwise anticipated.
Biogen reported more positive numbers for the firm’s biosimilars business in the first quarter of this year, although some of this growth was attributed to “accelerated sales” stemming from the COVID-19 pandemic. Meanwhile, the company revealed its latest thinking as it continues attempts to shield its key Tecfidera brand from competition in the US, following a fresh unfavorable patent ruling.
Tecfidera accounts for nearly one-third of Biogen's revenues, so the patent decision relieves one overhang for the company. However, other ANDA challenges are ongoing.