South Korean biotech firms are targeting the $26 billion biosimilar market opening up as patents expire on more than 10 blockbuster drugs in the United States this year. Biosimilars are copies of original biologic medicines made after their patents end. With this new opportunity in the world’s largest medical market, Korean pharmaceutical companies are launching their own biosimilars to compete.
According to the Korea Biotechnology Industry Organization (KoreaBio), citing Fierce Pharma, the top 10 blockbuster drugs that have lost or are set to lose exclusivity in the U.S. generated a combined $26.2 billion (38.2 trillion won) in sales last year. This estimate is based on pharmaceutical earnings reports and healthcare industry data.
Among the blockbuster drugs with expired patents, Johnson & Johnson’s autoimmune disease treatment Stelara led U.S. sales last year. Stelara’s global sales reached $10.36 billion, with $6.72 billion coming from the U.S. market alone. This figure surpasses the combined annual revenue of South Korea’s top 10 pharmaceutical and biotech companies.
With Stelara’s patent expiring last year, many global drugmakers have been developing biosimilars. Seven are already competing in the U.S. market, with more expected to launch soon.
South Korean pharmaceutical giants are also entering the Stelara biosimilar race. Samsung Bioepis was the first, launching Pyzchiva in the U.S. on Feb. 24. Celltrion and Dong-A ST have secured FDA approval for Steqeyma and Imuldosa, respectively, and plan to launch them later this year.
Samsung Bioepis and Celltrion are also gearing up to launch biosimilars for osteoporosis treatments in the U.S. The reference drugs, Prolia and Xgeva by Amgen, are widely used for osteoporosis and bone cancer. Last year, the two drugs generated $6.6 billion in global sales, with $4.39 billion coming from the U.S.
The expiration of blockbuster drug patents offers a key opportunity for South Korean biotech companies, which have focused on biosimilar development. Biosimilars, designed to deliver nearly identical efficacy at lower costs, align with U.S. healthcare policies aimed at reducing drug prices. According to KoreaBio’s Bio-Economic Research Center, the FDA has approved 68 biosimilars in the U.S. from 2015 to February this year. Of these, 20 are South Korean-made, making Korea the second-largest supplier after the U.S., which has 26.
South Korean companies are excelling in the biosimilar market by completing clinical trials faster than global competitors. Unlike generic drugs, which can be approved by replicating the chemical composition of the original without clinical trials, biosimilars require clinical evidence to prove they have the same biological properties, making them more difficult to develop. Phase 3 trials, the final and most time-consuming stage, are particularly challenging, but Korean biotech firms complete them up to a year faster than their global rivals, according to the U.S. clinical trial site ClinicalTrials.
