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Under the BPCIA, a biosimilar applicant submits its abbreviated BLA and then exchanges patent lists with the innovator in a staged process

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(4) Two Viable Translational Paths: First of all, it is necessary to give priority to including comparative functional indicators (target metabolite quantification, barrier markers, longitudinal changes in inflammation results) in clinical and preclinical studies to enhance the testability of the description of functional output to systemic inflammation

10.1002/prot.340230308 143 LeskA