HONG KONG – Marking another step in its path to profitability, South Korea's Samsung Bioepis Co. Ltd. reported a first approval in its home market for a biosimilar – Brenzys – based on Amgen Inc.'s blockbuster Enbrel (etanercept) to treat arthritis.
Set up six years ago, Incheon-based Samsung Bioepis is the biotech arm of the conglomerate. Samsung Bioepis and its partner Merck & Co., of Kenilworth, N.J., plan to launch Brenzys by the end of the year.
"We are very excited to receive this first regulatory approval of a biosimilar product resulting from our late-stage development pipeline," said Samsung Bioepis CEO Christopher Hansung Ko.
South Korea's Ministry of Food and Drug Safety approved the immunology drug developed as SB4. The biosimilar will be marketed in South Korea as Brenzys. The drug was proven to be an equivalent to Enbrel during tests, the results of which were released in June. Trials showed that the drug it is effective at reducing symptoms of rheumatoid arthritis on par with its reference product. The developer enrolled 596 patients from 10 countries for the study.
"We have a plan to launch the product within three or four months in Korea and in Europe by next year," Jamyung Cha, assistant manager of the corporate administration team at Samsung Bioepis, told BioWorld Today.
This first approval and the further launch plans for the drug could have major implications for Samsung Bioepis and its plan to go public on Nasdaq next year. Industry insiders expect the South Korean conglomerate to raise an estimated KRW1.5 trillion (US$1.3 billion) from its biologics division when it debuts on the U.S. stock market. (See BioWorld Today, May 21, 2014.)
"The approval of Brenzys in Korea is especially gratifying, and underscores our commitment to advancing health care through innovation and groundbreaking technology," said Ko. "We look forward to building on this progress in our collaboration with Merck."
Samsung Bioepis signed a sales agreement with Merck in 2013. The South Korean company is developing the drugs and Merck will handle commercialization.
"We are excited by the opportunity to deliver on the promise of biosimilars overall – and on the promise of Brenzys – by combining Merck's deep global customer expertise with the extensive development and manufacturing capabilities of Samsung Bioepis," said Dora Bibila, general manager at Merck Biosimilars.
The two companies expanded their collaboration last year to include SB9, an insulin glargine biosimilar candidate for the treatment of patients with type 1 and type 2 diabetes. SB9 is now in phase III trials. Merck presented positive phase I data for SB9 at the American Diabetes Association's annual meeting earlier this year.
Expecting South Korea to become a key market in Asia for biologics, the Samsung Group has been investing in the space for four years.
The company now has six candidates in its pipeline, including Brenzys and five other products.
In March, the company applied to the EMA for approval for its biosimilar version of Remicade (infliximab, Johnson & Johnson) – which Samsung Bioepis is developing as SB2 – for the treatment of rheumatic arthritis.
"We are hoping to launch SB2 next year in the EU and Korea as well," said Cha.
In July, Samsung also presented data from a phase III study of SB5, a biosimilar of Humira (adalimumab, Abbvie Inc.) for autoimmune diseases.
"We have developed SB5 following SB4 and SB2. Now we have developed biosimilars for three of the best-selling biologics for autoimmune disease," said Ko.
The biosimilar drug development unit of the Samsung Group booked an operating loss of $21.67 million last year. Execs said the firm aims to be profitable by 2019 with revenues targeted at $736.7 million in 2020. (See BioWorld Today, Aug. 26, 2015.)