Success for Bioepis as FDA approves a second Enbrel biosimilar

The US Food and Drug Administration (FDA) has approved a second biosimilar of Amgen’s Enbrel (etanercept), Samsung Bioepis’s Eticovo.

Korea’s Samsung Bioepis has seen regulatory approval for its etanercept biosimilar in numerous markets, including Korea, Europe, Australia, Canada, Brazil, Switzerland and Israel. Now the firm has had the molecule approved in the US under the brand name Eticovo.

This is the second biosimilar of Amgen’s autoimmune disease drug Enbrel to be approved by the FDA. In August 2016, Sandoz received approval for Erelzi across all the same indications as the reference product. However, Sandoz’ parent company Novartis continues to be embroiled in a legal dispute with Amgen and has so far been unable to launch Erelzi in the US.

According to a Samsung Bioepis spokesperson, “launch plans for Eticovo remain under review.”

Image: iStock/Waldemarus

For 2018, Enbrel pulled in $4.8 billion (€4.3 billion) for Amgen in US sales.

European regulators approved Samsung Bioepis’ etanercept in 2016. The product is sold by partner Biogen under the brand name Benepali. In 2018, sales of Benepali pulled in $485 million for the firm, and speaking during its recent Q1 financial call Biogen said “Benepali has been strengthening its leadership position in countries such as Germany, the UK, Denmark and Norway, shipping again more than one million doses in the quarter.”

For Samsung Bioepis, the FDA’s approval of Eticovo comes three months after the approval of Ontruzant, a version of Roche’s Herceptin (trastuzumab) and two years after the approval of Renflexis, a version of J&J’s Remicade (infliximab).