Korean biosimilars make inroads into Europe

[THE INVESTOR] Propelled by Samsung Bioepis and Celltrion, South Korean biopharmaceutical companies are gaining a foothold in Europe with their biosimilars, cheaper copycat versions of biologics.

Celltrion’s Remsima -- biosimilar replication of rheumatoid arthritis treatment drug Remicade -- and Samsung Bioepis’ Benepali -- biosimilar copy of Amgen’s rheumatoid arthritis treatment Enbrel – along with Flixabi, another Remicade biosimilar, are already selling in Europe, one of the world’ largest market for such drugs. 

Three other biosimilars are awaiting permission from the European Medicines Agency for sales in the region. They are Celltrion’s Truxima -- biosimilar of lymphatic cancer drug Rituxan -- and Samsung Bioepis’ SB5 and SB9, biosimilars referencing rheumatoid drug Humira and diabetes drug Lantus, respectively.

Celltrion’s Truxima, which applied for approval in October last year, is expected to receive a green light by end of this year. If approved, Celltrion will have two biosimilar products in line for the European market.

Samsung Bioepis, a unit of Samsung Group, anticipates its SB5 and SB9 to get the go-ahead by next year, considering it takes 14-16 months for the EMA to approve after receiving the application. 

“If approved, SB5 will join Benepali and Flixabi in Europe, which have already started to increase patient access to high-quality treatment options while driving down health care spending,” said Ko Han-sung, CEO of Samsung Bioepis, in a statement earlier this week.

With Celltrion’s plan to apply to EMA for Herzuma -- biosimilar of breast cancer treatment Herceptin -- in the second half of the year, more South Korean biosimilars are vying to enter the European market.

“Europe’s business market is friendly to (pharmaceutical firms) because the government is adopting biosimilars to reduce the burden from health insurance costs,” an official in the industry said. “(Companies) only need an approval from the EMA to enter the large European market, which is very appealing.”

By Ahn Sung-mi (sahn@heraldcorp.com)