EU Endorses Biosimilar Etanercept (SB4) from Samsung/Biogen Save

Reuters today reported that a copy of the blockbuster biotech drug Enbrel (SB4) was recommended for approval in Europe on Friday, making it the second so-called biosimilar antibody medicine to win such a green light from the continent's regulators.

The European Medicines Agency (EMA) said its experts backed the use of South Korean company Samsung Bioepis's version of etanercept, as Enbrel is known scientifically, for rheumatoid arthritis and other autoimmune diseases.

The drug will be sold in Europe by U.S. biotechnology group Biogen.

Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, is taking aim at that business with its copy of Enbrel, which will be marketed under the brand name Benepali.

Biosimilar etanercept, which was recently approved in South Korea, would be the second such antibody product to reach the market in Europe and its arrival is likely to intensify competition. European doctors are already able to prescribe biosimilar infliximab, a copy of Merck's Remicade.

Samsung Bioepis, which is also developing biosimilar copies of Remicade and AbbVie's Humira, said its aim was to bring "affordable, high-quality biologic treatment options" to patients in Europe.

After the green light from the EMA, the approval of biosimilar etanercept still needs to be formally ratified by the European Commission, a process that normally takes a couple of months.