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N Engl J Med 375:18341844 Holman RR, Bethel MA, Mentz RJ, Thompson VP, Lokhnygina Y, Buse JB, Chan JC, Choi J, Gustavson SM, Iqbal N, Maggioni AP, Marso SP, hman P, Pagidipati NJ, Poulter N, Ramachandran A, Zinman B, Hernandez AF (2017) EXSCEL Study Group

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95% CI, 0.54-1.11) did not reach statistical significance

Comparative pharmacokinetic and pharmacodynamic studies in humans are typically required, along with a comparative immunogenicity assessment measuring the incidence and titer of anti-drug antibodies in the biosimilar arm versus the reference arm