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a Phase III study compared the two products in RA not sufficiently controlled by methotrexate in order to establish equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles
doi: 10.1001/jama.2019.2942 [DOI] [PMC free article] [PubMed] [Google Scholar] 99
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The FDA based its expansion for all stages of liver disease on the data from a Phase I trial that showed no new safety signals
