Biogen Announces Approval for Biosimilar of Amgen’s Enbrel

gloved hand withdraws drug solution with syringe

Biogen Inc. announced this past Saturday that the European Commission has approved Samsung Bioepis’s proposed biosimilar of Amgen’s Enbrel (etanercept). Enbrel is a biologic drug used to treat five different inflammatory conditions, including rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis. This is the first biosimilar of Enbrel approved in Europe.

Biogen teamed up with Samsung Biologics in 2011 to form Samsung Bioepis, a company devoted to the biopharmaceutical and biosimilar space. Samsung Bioepis is also partnered with Merck & Co., Inc. to develop biosimilars of Remicade, Humira, and Herceptin.

Samsung Bioepis will market its Enbrel biosimilar in Europe under the name Benepali. According to Samsung Bioepis, Benepali performed comparably to Enbrel in reducing symptoms of rheumatoid arthritis in a Phase III trial involving 596 patients.

Samsung Bioepis plans to launch Benepali in Europe in the coming weeks.

For more biosimilar news, stay tuned to Big Molecule Watch.