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First etanercept biosimilar approved in the European Union
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Samsung Bioepis Co., Ltd. announced it has received approval from the European Commission to market Benepali, its etanercept biosimilar, for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.
The approval follows a positive opinion granted in November 2015 by the European Medicines Agency for the product, then known as SB4.
“In just under 4 years, we successfully developed, tested and obtained regulatory approval for Benepali, a high-quality biologic medicine that will drive down health care costs and increase patient access to one of the most widely used treatment options for immunological diseases across Europe,” Christopher Hansung Ko, president and chief executive officer of Samsung Bioepis, said in a press release.
The biosimilar to etanercept underwent a phase 3 study in which 80.8% of patients on the medicine responded with at least a 20% improvement compared with 81.5% of patients who received the originator etanercept (Enbrel, Amgen).
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