Enter 2021.03.27 06:00
Celltrion leads to Phase 3 clinical trials… “Completed next year”
Samsung Bioepis and Dong-A ST pursue
According to the bio industry on the 27th, Celltrion (068270), Samsung Bioepis, Dong-A ST (170900)Three companies, including drugs, are undergoing global clinical trials as candidates for treatment. Stellar is a drug that has been approved for use in the treatment of various autoimmune diseases such as psoriasis, psoriatic arthritis, and Crohn’s disease, and is commercially available in the United States, Europe, and Korea. Last year, it generated sales of about 7.7 billion dollars (about 870 trillion won). With an increase of more than 20% compared to the previous year (about $6.4 billion in 2019), the patents expired in September 2023 and July 2024 in the U.S. and Europe, respectively, making it possible to sell generic drugs.
An industry insider explained, “When the patent for an original drug expires, the original drug and the generic drug will divide the market by 50%,” said an industry official. “It can be considered that half of the market is shared by competitors of generic drugs.” In the case of Stellara, there is an opportunity to share sales of more than 4 trillion won per year.
Globally, it is known that only a few companies, including Amgen in the US, Bioterra Solutions in China, and Bioep in Switzerland, are conducting clinical trials for the Stellara generic drug along with three domestic companies. As of last year, it is an opportunity that cannot be given up for Celltrion with annual sales of about 1.8 trillion won, Samsung Bioepis and Dong-A ST with hundreds of billions of billion won.
As for the clinical rate, Celltrion is the fastest among the three companies. Celltrion entered phase 3 clinical trials for 446 patients in Europe in January as a candidate substance’CT-P43′. It plans to obtain interim results within this year and complete it by December next year, and apply for permission to the US and European health authorities in time for the expiration of the original patent.
Samsung Bioepis only started phase 1 clinical trials on 201 European patients of the candidate substance’SB17′ on the 26th of last month. However, the company explained that if the clinical trial of the generic drug goes through a phase 1 trial that sees safety for about 6 months, it is possible to shorten the period as it can skip phase 2 and enter phase 3 immediately from the next step of evaluating efficacy. An official from Samsung Bioepis said, “We are reviewing methods such as’overlap’ in which phases 1 and 3 are simultaneously conducted to complete the clinical trial before the original patent expires.”
Dong-A ST is planning to start the trial within this month after receiving approval for the clinical trial of the candidate substance’DMB-3115′ from the US Food and Drug Administration (FDA) in January. It is also undergoing a phase 3 clinical application process in Europe.
Dong-A ST, whose sales and performance fell by 4.2% and 40.2% from the previous year, respectively, plans to improve future performance through sales of Stellara generic drugs. Dong-A ST Chairman Uhm Dae-sik said at a regular shareholders’ meeting on the 24th, “The overall sales fell due to the new coronavirus infection (Corona 19) pandemic last year, but in the specialty drug sector, we achieved sales that exceeded the market growth rate.” In the field of ), we will focus on the development of Stellara’s biosimilars this year.”