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The strategic logic is straightforward: even if a biosimilar manufacturer can replicate the antibody sequence after the composition patent expires, it cannot replicate a specific dosing regimen covered by a valid method-of-use patent, or a specific prefilled syringe design covered by a device patent, without infringement risk

Strategic Breakthrough Awards Create a New Funding Tier The reauthorization formally established the Strategic Breakthrough Award, a new funding mechanism that scales up the transition-focused programs the Department had already been running informally across its components

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