The competition among South Korea's pharmaceutical and biotech industries is intensifying over Dupixent, a blockbuster drug with annual global sales reaching $17.8 billion (approximately 27 trillion won). Following Jongkundang's entry into European clinical trials, Daewoong Pharmaceutical and Samsung Bioepis are also vying for market dominance, positioning themselves in the emerging biosimilar battleground.
As of June 8, industry sources indicate that Dupixent, a dual interleukin inhibitor co-developed by Sanofi and Regeneron, is approaching its patent expiration in 2029. It has established a dominant market share of 90% in South Korea's severe atopic dermatitis treatment sector.
The industry's interest in Dupixent extends beyond its market share; it also reflects significant growth potential. Sanofi highlighted in its earnings report last year that the drug's growth is supported by "steady growth across eight indications." In a recent earnings call for the first quarter of this year, the company noted, "Dupixent continues to show robust growth across all indications."
Initially approved for treating severe atopic dermatitis in adults, Dupixent has expanded its indications to include asthma, eosinophilic esophagitis, chronic rhinosinusitis, and chronic obstructive pulmonary disease (COPD). An industry insider remarked, "The potential for market growth remains high even at the time of patent expiration, given the diverse indications. This makes it a commercially viable product that traditional pharmaceutical companies are considering as a new growth driver."
In South Korea, Jongkundang is leading the charge. Earlier this year, the company received clinical trial phase 1 approval from the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its candidate drug CKD-706. This trial will assess pharmacokinetic equivalence, safety, and immunogenicity against the original drug in healthy adults. Jongkundang is the first to enter European clinical trials for a Dupixent biosimilar, giving it a competitive edge in the global market.
Daewoong Pharmaceutical, which established a biosimilar division last year, has chosen Dupixent as its first development product. The company has recruited Dr. Hong Seung-seo, a biosimilar expert from Celltrion, to lead the division. Recently, Daewoong signed a development, production, and commercialization partnership with the China-based global contract development and manufacturing organization, Chime Biologics. This collaboration aims to accelerate development and target future global market entry.
Samsung Bioepis is also eyeing the follow-up market. Its parent company, Samsung Epics Holdings, unveiled six new biosimilar candidates, including dupilumab, at this year's JP Morgan Healthcare Conference, announcing plans to expand its entire biosimilar portfolio to 20 products by 2030.
An industry expert noted, "Dupixent is expected to continue its growth trajectory even after patent expiration. As the indications expand, the competition among biosimilar companies will become increasingly fierce."
* This article has been translated by AI.
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