Merck’s Revised Biosimilar Strategy Poised To Deliver
This article was originally published in The Pink Sheet Daily
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.
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351(k) application relies on data extrapolation from Phase III trial in rheumatoid arthritis to support approval across infliximab's indications, including inflammatory bowel disease.
Within just three and a half years since its establishment, Samsung Bioepis has received its first regulatory approval for a biosimilar, meaning the Samsung Group affiliate is now set to release its version of Amgen’s Enbrel (etanercept) in South Korea late this year or early next. It will be the fourth locally developed biosimilar to hit the domestic market and is expected to be priced at about a 30% discount.
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.