As the first biosimilar of Samsung Bioepis has received approval in Korea, Samsung Group’s bio business is expected to expand in earnest.
Samsung announced on Sept. 7 that the Ministry of Food and Drug Safety (MFDS) has approved Brenzys. It is a biosimlar version of Enbrel, a blockbuster arthritis drug from the global pharmaceutical company Pfizer. Its global sales reach US$8.7 billion (10.48 trillion won) a year around the world. Given its large scale of the market, it is hard for another company to be recognized for its technology, but Samsung has worked hard from the initial stage of product development.
In fact, Samsung had carried out clinical tests in many countries around the world from the early stage of development in order to break into the global markets, rather than the domestic market. The company conducted a Phase III clinical study in 596 patients with rheumatoid arthritis (RA) from 73 hospitals in 10 countries for 24 weeks. The results were presented at the Annual Congress of the European League Against Rheumatism (EULAR) in June.
According to the clinical studies results published in EULAR’s official medical journal, Brenzys showed an equivalent efficacy to Enbrel. About 78.1 percent of RA patients, who had received Brenzys for 24 weeks, had a 20 percent response criterion, which is similar to Enbrel's 80.3 percent.
With the approval of its first biosimilar product, Samsung Bioepis can now be recognized for its ability to develop biosimilars, and accelerate the development of its next products.
In addition to Brenzys, the company is also carrying out Phase III clinical trials for other biosimilars of Humira and Remicade, which are also RA drugs from global pharmaceutical companies, and of Herceptin, the breast cancer treatment. Accordingly, Samsung Bioepis is expected to get approval for more of its biosimilars after next year. An official from the MFDS said, “The four biosimilars developed in the nation are antibody drugs, which are difficult to develop due to their large molecular weights and complex structures. Domestic pharmaceutical companies are now developing 13 items, 60 percent of a total of 22 biosimilars, which are currently conducting clinical tests.”
The bio business status within the group is expected to raise. Samsung BioLogics, a mother company of Samsung Bioepis, has received investment funds of 1.18 trillion won (US$978.49 million) from the group. It is a considerable amount of money to invest in a new business. Also, Samsung Bioepis plans to secure additional investment funds of some US$1 billion (1.2 trillion won) through the IPO on the NASDAQ stock market in the first half of next year.