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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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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.

Coronavirus Boosts Biogen Biosimilars In First Quarter

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