Samsung Prepping For First Biosimilar Launch
This article was originally published in The Pink Sheet Daily
Samsung Bioepis' biosimilar version of Amgen's rheumatoid arthritis blockbuster Enbrel (etanercept) is set to become the firm’s first biosimilar product to hit the market, possibly being released in South Korea late this year and in Europe in the first half of next year.
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New clinical study data have been presented to a major international meeting on Samsung Bioepis and Celltrion's major biosimilar contenders as well as Boryung Pharm's hypertension therapy, all of which are South Korean drugs carrying their developer’s ambitions of overseas market launches or expansion.
Samsung's biosimilar projects seem to be progressing smoothly, with its affiliate Samsung Bioepis in the final stage of a Phase III global clinical study for SB9, its biosimilar version of Sanofi's blockbuster Lantus (insulin glargine), for which an approval filing is planned in the U.S. in the latter half of this year and in Europe early next year.
The big pharma has five biosimilars in Phase III development with its partner Samsung Bioepis, and expects to file them for regulatory approval in 2015 and 2016.