firstwordpharmaJuly 25, 2017
Tag: Samsung , biosimilar
According to industry sources, Samsung Bioepis' biosimilar Lusduna Nexvue received tentative approval from the FDA, reported The Korea Herald.
The diabetes therapy, developed in partnership with Merck & Co., was approved because it satisfied all regulatory rules regarding clinical and nonclinical safety for follow-on biologics, local observers said.
However, Lusduna Nexvue, which was approved in Europe as a biosimilar in January, is being held back because of the remaining patent period controlled by Sanofi.
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