Samsung Biologics, the sales growth of biosimilar drugs drives the simultaneous increase in sales revenue and operating profit

Samsung Bioepis, backed by expanded biosimilar drug sales in the first quarter of 2026 and the performance from newly launched products, delivered double growth in both revenue and operating profit.

Samsung Bioepis announced on the 23rd that its operating profit in the first quarter of this year was 144 billion won, up 13% from the same period last year. Sales for the same period were 454.9 billion won, up 14% year over year. This result has already met the company’s goal of achieving at least 10% annual sales growth—set by the company in January this year—starting from the first quarter. Biosimilar drugs refer to “concept” generic drugs developed to be similar in quality and efficacy to the original biologic drugs; they typically enter the market after patent expiration, leveraging price competitiveness.

The performance is interpreted as the combined effect of growth from both existing products and new products in the European and U.S. markets. The company said that sales of existing products have continued to be steady, including SB4, a biosimilar drug that is marking 10 years on the market in Europe. In the United States, the launch of new products has helped drive sales expansion. Currently, four products are sold directly in Europe. The biosimilar drug SB15 of aflibercept has reached an agreement with the original developer on launch timing; it is planned for this month’s launch in Europe and January 2027’s launch in the United States. In the United States, the company signed a private label supply agreement for the biosimilar drug SB16 of Prolia in October last year with CVS Caremark, one of the three largest pharmacy benefit management companies, and has rolled it out to the market. Pharmacy benefit management companies are operators that coordinate drug benefits and distribution terms among insurers, pharmaceutical companies, and pharmacies, and they have a major impact on product promotion in the U.S. market.

In addition to its biosimilar business, the company is also advancing new drug R&D in parallel. Last month, the first antibody-drug conjugate (ADC) new drug candidate entered global Phase I clinical trials. ADC is a technology that combines a drug with an antibody, concentrating drug effects on specific cancer cells and the like; in recent times, it has been regarded by the global pharmaceutical industry as an area with substantial growth potential. In addition, a second new drug candidate co-developed with China’s Frontline is currently in the preclinical stage. This has been interpreted as the company’s strategy to further cultivate its own new drug development capabilities, moving from biosimilars with existing generic-like characteristics to new drug R&D.

The consolidated results of Samsung Epis Holdings, a holding company under Samsung, also turned profitable. Samsung Epis Holdings, established in November last year, recorded sales of 453.9 billion won and an operating profit of 90.5 billion won in the first quarter of this year. The company said that non-cash accounting adjustments related to purchase price allocation (PPA), such as amortization of development costs arising from re-evaluating asset values after the acquisition, have been reflected in the results. Based on consolidated reporting, sales were 251.7 billion won in November and December last year, with an operating loss of 63.6 billion won, but the company turned profitable in this quarter. However, considering external uncertainties such as global economic changes and exchange-rate fluctuations, the company maintained its outlook issued at the beginning of the year for sales growth of more than 10%. This trend suggests that the momentum for future improvements in performance may continue, depending on the pace of overseas market penetration of biosimilars and the progress of new drug development.