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The preparation is then made by a state-licensed 503A compounding pharmacy (patient-specific) or, for office or batch use, sourced from an FDA-registered 503B outsourcing facility [14]
is supported by the Canada Research Chair Program, a BBDC-Novo Nordisk Chair and CIHR grant 123391 and 154321
All procedures were performed during the autumn season, which corresponds to the natural breeding period for sheep
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
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