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Nichi-Iko targets substitution

Executive Summary

Nichi-Iko says it is in the final stages of conducting an ‘interchangeability’ Phase III clinical trial in the US to support a biosimilar infliximab filing with the US Food and DrugAdministration (FDA) next year. The Japanese company has already introduced biosimilar infliximab in its domestic market following an approval granted in September last year.

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