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  • SB16 has been approved for phase III clinical trial
  • by Lee, Tak-Sun | translator Choi HeeYoung | Dec 7, 2020 06:06am
The MFDS, approved phase III clinical trial plan, accelerated domestic development
 ¡ã Samsung Bioepis headquarters
Samsung Bioepis is the first in Korea to enter Phase III clinical trial of Prolia's biosimilar, an osteoporosis treatment.

The MFDS approved the Phase III clinical trial protocol for a biosimilar candidate for Prolia, SB16, which Samsung Bioepis applied on the 1st.

Prolia developed by Amgen was approved in Korea in September 2014. It is the first biological agent to appear as a treatment for osteoporosis and is jointly sold by Chong Kun Dang in Korea.

Based on IQVIA, sales in the first half of this year alone reached ₩34.9 billion, an increase of 102.7% from the same period last year.

Samsung Bioepis started Phase I clinical trial of Prolia's biosimilar in France in October. Multinational clinical tr
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