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Samsung Bioepis biosimilar wins tentative approval in US

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.

Previous:FDA unveils plan to eliminate orphan designation backlog

Next:Merck & Co., Samsung Bioepis introduce Remicade biosimilar Renflexis in US

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