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Samsung Bioepis Humira biosimilar gets accepted for EMA review

pharmafile | July 18, 2016 | News story | Research and Development, Sales and Marketing EMA, Humira, Samsung Bioepis, application 

The European Medicines Agency (EMA) has accepted for review the marketing authorisation application from Samsung Bioepis for their biosimilar version of blockbuster drug, Humira (adalimumab).

SB5 is the third anti-TNF-α biosimilar candidate submitted to the EMA by Samsung Bioepis. Biosimilar versions of other high-selling drugs Enbrel (etanercept) and Remicade (infliximab) have been approved in the EU under the brand names Benepali and Flixabi.

The marketing authorisation application submitted is based on data from a year long Phase III study where patients, with moderate rheumatoid arthritis despite methotrexate therapy, were randomised to take the biosimilar or originator for the full duration or to switch half way through. No significant differences in ARC20 response rates were observed across the treatment arms.

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Christopher Hansung Ko, president and CEO of Samsung Bioepis, says: “If approved, SB5 will join Benepali and Flixabi in Europe, which have already started to increase patient access to high-quality treatment options while driving down healthcare spending. We will continue to work hard to advance one of the industry’s largest biosimilar pipelines, so that more patients can access affordable medicines without any compromise in the quality of treatment.”

Sean Murray

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