Samsung Bioepis Surpasses 1 Trillion KRW in Cumulative Sales Within 3 Quarters

Samsung Bioepis announced on the 24th that its third-quarter performance this year recorded sales of 330.3 billion KRW and operating profit of 67.9 billion KRW. Compared to the same period last year, sales grew by 26% and operating profit by 38%.

Exterior view of Samsung Bioepis headquarters.
[Photo by Samsung Bioepis]

On a cumulative basis this year, sales reached 1.1403 trillion KRW and operating profit 363.1 billion KRW, successfully surpassing 1 trillion KRW in sales within the first three quarters following last year's first annual sales breakthrough of 1 trillion KRW. Compared to the cumulative third quarter of last year, sales increased by 56% and operating profit by 186%.

Samsung Bioepis cited milestone achievements from research and development (R&D) outcomes as the biggest contributing factor to this growth. Since milestones do not recognize separate costs, they can simultaneously boost both sales and operating profit. In the first half of this year, Samsung Bioepis received a total of 220.5 billion KRW in milestones from its partners Biogen and Sandoz, following the U.S. approval of the biosimilar Eylea, Opdivo, and the U.S. and European approvals of the Stelara biosimilar, Fiztchiva.

Additionally, Opdivo recently received a positive opinion for marketing authorization from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA), raising expectations for additional milestone receipts within the year. The European drug approval process typically proceeds with the CHMP review followed by a positive opinion, after which the European Union (EU) Commission grants final approval usually within 2 to 3 months.

Samsung Bioepis plans to secure momentum for sustained growth through new product launches, follow-up biosimilars, and new drug development. The company introduced Fiztchiva in Europe last July and plans to enter the U.S. market in February next year. Among follow-up pipelines, it is progressing global major country approval procedures for SB16, developed as a biosimilar of Prolia, while SB27, developed as a biosimilar of Keytruda?the world's top-selling drug?is accelerating development speed through an overlapping strategy conducting Phase 1 and Phase 3 clinical trials simultaneously.

Beyond biosimilars, promising new drugs are also under development in basic research and preclinical stages. Through open innovation with Intusell, Samsung Bioepis is jointly developing antibody-drug conjugate (ADC) new drugs, while utilizing its own specialized research personnel to explore new drug candidates in various fields such as gene therapy.

This content was produced with the assistance of AI translation services.