Samsung Bioepis said Sunday it has won official approval from the European Commission to begin selling Benepali, its biosimilar replication of Amgen’s blockbuster rheumatoid arthritis treatment Enbrel (Etanercept), in Europe.

The approval marks an important milestone in Samsung Group’s latest push to expand into the promising field of biosimilar production, and elevates the drugmaker’s market value in a forthcoming public listing on the U.S. Nasdaq this year.

Benepali is the first Enbrel biosimilar to be approved in the EU, where Amgen’s top-selling arthritis drug accounts for approximately $10 billion of all biologics sold in the European region.

Samsung’s biosimilar will be exclusively marketed and distributed as Benepali by Biogen in the EU member states in accordance with a commercialization partnership signed between Samsung Bioepis and Biogen in 2013.

“The approval of Benapali and its subsequent launch in Europe are major milestones for Samsung Bioepis,” said Ko Han-sung, president and CEO of Samsung Bioepis in a statement.

Benepali will “drive down health care costs and increase patient access to one of the most widely used treatment options for immunological diseases across Europe,” said the Samsung Bioepis CEO.

Biosimilars refer to lower-cost copies of brand-name biologic treatments which have lost or are scheduled to lose their patent protection. A number of companies around the world, including Samsung, have jumped into this newly-emerging segment, seeking high growth potential and profits. 

In addition to Benepali, Samsung Bioepis is currently developing five other biosimilars which reference some of the world’s top-selling biologics including Remicade, Humira, Herceptin and Avastin. Samsung Bioepis has also invested in a Lantus biosimilar under development by Merck Co.

“Over the coming months, a number of them will be filed for regulatory approval in markets across the world,” Ko said, noting that “multiple biosimilar candidates are in Phase 3 clinical trials.” 

Benepali, locally known as Brenzys, and SB2, Samsung’s Remicade (Infliximab) biosimilar, were already approved for commercialization in South Korea last year.

SB2, being sold as Renflexis in Korea, is expected to enter European markets in the near future as it awaits final approval from the EMA.

Established in 2012, Samsung Bioepis is an affiliate of Samsung Group specializing in biosimilars development, formed as a joint venture between Samsung BioLogics and U.S.-based Biogen.

By Sohn Ji-young (jys@heraldcorp.com)