Showing unprecedented development speed, Samsung has succeeded in developing all biosimilars of the global three autoimmune disorder treatments, including of Humira, the best selling drug in the world.
Samsung Bioepis, a biotech subsidiary of the Samsung Group, announced on July 6 that the global Phase 3 clinical studies of its biosimilar autoimmune disorder treatment “SB5” demonstrated equivalent effects to the medicine “Humira.” Accordingly, the company has completed clinical trials of biosimilars of the global three autoimmune disorder treatments three years since its founding in 2012. Even though it started later than other multinational pharmaceutical companies, its commercialization is a step ahead.
Developed by U.S.-based pharmaceutical company AbbVie, Humira is a medicine to treat autoimmune disorders, including rheumatoid arthritis and ankylosing spondylitis. It is considered to be the best-selling medicine in the world with sales of US$12.9 billion (14.5 trillion won) last year. The global sales of Enbre and Remicade, the originator medicines of autoimmune disease treatments “SB4” and “SB2” previously developed by Samsung, also reach 10 trillion won (US$8.89 billion) each per year. It means that the three autoimmune disease treatment markets surpass 30 trillion won (US$26.7 billion) on an annual basis.
Samsung submitted the Marketing Authorization Application (MAA) for SB4 and SB2 to the European Medicines Agency (EMA) in Dec. last year and March this year, respectively. The company is expected to sell the products in Europe in the first half of next year. Also, it will submit the MAA for SB5 to the EMA next year.
Samsung Bioepis CEO Koh Han-seung said, “Samsung Bioepis is the only company that succeeded in all three phases of its clinical trials of the three products. Once beginning the sale of all three products, the company will have differentiated competitiveness that other companies cannot keep up with.”
The company is also in the last stage of the Phase Three clinical trials of breast cancer treatment “SB3,” a biosimilar of Hercepti, and in Phase One clinical trials of colorectal cancer treatment “SB8,” a biosimilar of Avastin, accelerating the development of anti-cancer drugs. Also, it will submit the MAA for antidiabetics “SB9,” a biosimilar of Lantus, at the end of this year. Securing a total of 13 biosimilar products in the future, including six products currently under development, Samsung Bioepis is planning to become a leading biotechnology company in the world by developing an additional two to three biobetter products, which are considered to be new drugs.
In order to succeed in the biosimilar business, the production capacity to supply products in bulk in time is the key to success and technology. For this, Samsung Biologics is in charge of the production. The company is planning to have the production capacity of one of the world’s top three by starting the operation of a second factory with a production capacity of 150,000 tons at the beginning of next year, as well as the current first factory with a production capacity of 30,000 tons. Also, the company has applied to the board of directors for approval to start construction of the third factory in Oct. this year, and will plan to secure a production capacity of more than 400,000 tons by 2020 through the construction of a fourth factory.
The Samsung Group expects to post 4 trillion won (US$3.55 billion) in annual sales and 2 trillion won (US$1.78 billion) in operating profits through Samsung Bioepis and Samsung Biologics by 2025.