Traditional pharmas join in the Dupixent biosimilar race

Daewoong partners with China's Chime Biologics to accelerate global expansion

CKD Begins European Phase I Trial of CKD-706…Samsung Bioepis and KyongDong Pharmaceutical also start development

Global sales expected to increase to KRW 30 trillion… patents set to expire sequentially in major countries after 2031.

Korean pharmaceutical and biotechnology companies are increasingly entering the race to develop biosimilar versions of Dupixent (dupilumab), a blockbuster biologic with annual global sales approaching KRW 27 trillion.

According to industry sources, Daewoong Pharmaceutical signed an agreement on May 28 with Chime Biologics, a global Chinese contract development and manufacturing organization (CDMO), to collaborate on the development, manufacturing, and commercialization of a Dupixent biosimilar. Under the agreement, the companies will leverage Chime Biologics' biologics development and manufacturing capabilities to develop the biosimilar, while Daewoong Pharmaceutical will lead commercialization efforts in major international markets.

Daewoong established a dedicated biosimilar business division in June last year, and the Dupixent biosimilar has reportedly been identified as one of its initial strategic targets.

Chime Biologics operates KUBio, a modular biologics manufacturing platform, and is regarded as having manufacturing capabilities that meet global cGMP standards required by both the U.S. FDA and the European Medicines Agency (EMA). The company has also expanded partnerships with Korean biotech firms such as MedPacto and Panolos Bioscience.

CKD and Samsung Bioepis pursue ‘independent development,’ Daewoong and KyongBo seek ‘joint development’…targets global market

Prior to Daewoong's announcement, Chong Kun Dang (CKD), Samsung Bioepis, and KyongBo Pharmaceutical had already formalized their strategies for entering the Dupixent biosimilar market.

In January, CKD received approval to initiate a European Phase I trial for its biosimilar candidate CKD-706. The study will evaluate pharmacokinetic equivalence to Dupixent in healthy adult volunteers while also comparing pharmacodynamics, safety, and immunogenicity. Industry observers assess CKD to be among the most advanced Korean companies in Dupixent biosimilar development.

Samsung Bioepis announced at the J.P. Morgan Healthcare Conference 2026 that it had begun development of 7 blockbuster biosimilars, including a Dupixent biosimilar.

KyongBo Pharmaceutical signed a comprehensive collaboration agreement with Protium Science in September last year and formally announced its Dupixent biosimilar development program in December.

The participating companies are pursuing different development models. CKD has chosen an independent development strategy aimed at maximizing long-term profitability through its own R&D capabilities. Samsung Bioepis is likewise expected to pursue an in-house development approach, in line with its previous biosimilar programs.

By contrast, Daewoong Pharmaceutical and KyongBo Pharmaceutical are pursuing joint development. The companies are employing a practical strategy to lower early-stage development risks and improve process efficiency through joint development.

Dupixent sales expected to reach USD 30 billion…substance patent to expire around 2030 in major countries

Commercialization strategies are also expected to differ once the companies complete development . Samsung Bioepis is likely to pursue a two-track strategy combining direct sales and global partnerships, similar to its existing biosimilar portfolio.

Daewoong plans to leverage the global commercialization experience gained through its botulinum toxin product Nabota to support future marketing of a Dupixent biosimilar. KyongBo Pharmaceutical, which is relatively new to the biologics sector, is expected to explore licensing-out opportunities or co-marketing models with large multinational pharmaceutical companies through its partnership with Protium Science.

Dupixent generated USD 17.8 billion in annual sales last year, making it one of Sanofi's most successful products.

The drug has maintained strong growth through successive indication expansions across immune-mediated diseases, including atopic dermatitis and asthma. More recently, indications have been expanded to include ▲ chronic rhinosinusitis with nasal polyps (CRSwNP), ▲ prurigo nodularis, ▲ eosinophilic esophagitis (EoE), and ▲ chronic obstructive pulmonary disease (COPD). Industry analysts project that global sales could exceed USD 20 billion (KRW 30.3 trillion) before patent expiration.

Dupixent's core composition patents are scheduled to expire between 2029 and 2031 in major markets. Although Sanofi is pursuing an aggressive patent defense strategy through formulation changes and additional patent filings that could potentially extend exclusivity by up to a decade, the market generally expects a large-scale biosimilar market opportunity to emerge around 2030.