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In the context of long COVID, Ta1 addresses the immune exhaustion and dysregulation that characterizes the condition, helping to restore appropriate T cell function, support viral clearance, and modulate the inflammatory cytokine environment

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At the same time, the process reinforces the importance of evaluating safety, quality, and the available scientific evidence before regulatory decisions are made

Biologic Exclusivity under the BPCIA, as noted, provides 12 years from the date of approval for reference products, plus a four-year data exclusivity period during which no biosimilar application can be submitted [29]