Bioepis biosimilar of Amgen's Prolia starts Phase 3 clinical trials

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Bioepis biosimilar of Amgen's Prolia starts Phase 3 clinical trials

Published: 15 Dec. 2020, 19:17 Updated: 15 Dec. 2020, 19:53

Samsung Bioepis' headquarters in Incheon. [SAMSUNG BIOEPIS]

Samsung Bioepis’ SB16, a biosimilar to osteoporosis treatment Prolia, has started Phase 3 clinical trials, the company said Tuesday.

The drug is an identical copy of the osteoporosis treatment denosumab, better known as U.S. bio firm Amgen’s Prolia.
Biosimilars are biological products that are approved based on proof that they are highly similar to other FDA-approved products.

Prolia’s patent expires in 2022 for most parts of Europe and 2025 in the United States, opening the market for biosimilars like SB16. Last year alone, Prolia generated a revenue of $2.6 billion globally.

Phase 3 clinical trials took off in November in six different countries on 432 women suffering from osteoporosis after menopause. The tests aim to compare the safety and efficacy with the Prolia original.

A joint venture between Samsung Biologics and U.S. bio firm Biogen, Samsung Bioepis had initiated Phase 1 clinical trials in October this year.

SB16 is the company’s ninth biosimilar. Among them, three are now in Phase 3 clinical trials. The other six have completed tests and four have obtained sales approval in Korea, United States and Europe.

BY SONG KYOUNG-SON [song.kyoungson@joongang.co.kr]