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Bioepis’ Imraldi biosimilar set to reach Europe by October

Apr 07,2018
Korean biopharmaceutical firm Samsung Bioepis said Friday its biosimilar Imraldi is set to reach the European market in October following the settling of a patent dispute with the drug’s original manufacturer AbbVie.

The two companies reached an agreement, clearing the way for the worldwide commercialization of Imraldi, a copy of immune diseases drug Humira, Samsung Bioepis said. Imraldi is also known as SB5.

“We welcome this agreement, which clears the way for the drug to be approved for markets across the world. The earliest impact of this agreement will likely be seen in Europe, where SB5 has already been approved and is expected to become our third TNF inhibitor available in the region,” said Kim Jay-woo, a senior vice president.

The European Commission (EC) earlier accepted Samsung Bioepis’ application to sell Imraldi in 28 EU member states, as well as Norway, Iceland and Liechtenstein, according to the company. It said the drug will be commercialized in Europe by Biogen.

Imraldi could also be allowed to be sold in the United States from 2023 onward if the company receives regulatory approval.

Samsung Bioepis was established in 2012 in a joint venture between Samsung Biologics and Biogen. Samsung BioLogics is a biopharmaceutical unit of Korea’s top conglomerate, Samsung Group.


Yonhap