Samsung Bioepis' infliximab biosimilar Renflexis approved in Korea

The drug – named Renflexis – was approved by Korea’s Ministry of Food and Drug Safety (MFDS) for use in the treatment of a range of autoimmune disorders.

Samsung Bioepis, which is a venture set up by Biogen and Samsung Biologics, had its first biosimilar Brenzys - a version of Amgen's Enbrel (etanercept) - approved in Korea in September.

Both Renflexis and Brenzys are made by Biogen at its plant in Hillerød, Denmark according spokeswoman Shannon Altimari.

She told us that the facility, which houses 90,000 litres of stainless steel bioreactor capacity, also produces Biogen's drugs Tysabri (natalizumab) and Avonex​ (interferon beta-1a),

Also Like Brenzys, Renflexis will be sold by MSD Korea - the local subsidiary of US drugmaker Merck & Co - under a marketing and commercialisation deal signed with Samsung Bioepis in 2013.

Speedy launch​

MSD Korea announced that sales of Brenzys began on December 3, which suggests that Renflexis is likely to be available in Korea soon.

Samsung Bioepis is currently considering an initial public offering (IPO) on the NASDAQ​.

CEO Christopher Hansung Ko said: “We look forward to the introduction of Renflexis in Korea, where patients suffering from autoimmune diseases will soon have access to an affordable, high-quality biologic treatment option​.”

He also indicated the approval will not be the last the firm seeks in Korea.

“With an extensive pipeline of biosimilars on the way, we will continue to leverage our strengths in product development and quality assurance to bring these life-enhancing medications to patients who need them most​.”