Dongkook Pharmaceutical has begun developing a generic version of Chong Kun Dang Pharmaceutical’s diabetes drug Duvie (lobeglitazone).
According to the Ministry of Food and Drug Safety on the 27th, Dongkook Pharmaceutical on March 13 received approval to conduct a bioequivalence study for “DKF-457.” Duvie, developed by Chong Kun Dang, is described as South Korea’s first thiazolidinedione (TZD) class diabetes treatment, with annual prescriptions totaling about 20 billion won.
TZD drugs once led the diabetes market in the 2000s, but their use declined after cardiovascular side-effect concerns emerged over GlaxoSmithKline’s Avandia (rosiglitazone). Dipeptidyl peptidase-4 (DPP-4) inhibitors later took the lead, and the market is now dominated by DPP-4 inhibitors and sodium-glucose cotransporter-2 (SGLT-2) inhibitors.
While TZDs represent a smaller segment today, they continue to be prescribed for certain patients, including those with high insulin resistance or fatty liver disease. Interest has recently returned to combining TZDs with SGLT-2 inhibitors, and the move into TZD generics is being viewed as part of a strategy to broaden options for combination prescribing.
Dongkook Pharmaceutical has been seeking to expand its share of the diabetes market in prescription drugs since 2023. It said it has 15 diabetes-related products, including Tenelican, Daplejin, Sitakan and the insulin injection Glazia, along with treatments for chronic conditions that often accompany diabetes, such as hypertension and high cholesterol. A company official said, “At the research stage, the flagship pipeline is DKF-447, a diabetes treatment that has completed product approval, and we plan to continue expanding the diabetes pipeline.”
Competition in the Duvie generic market has already begun. Shin Poong Pharmaceutical started development first last year, setting up a race for generics. The substance patent is set to expire March 21 next year. A pharmaceutical industry official said competition is already overheated in markets centered on blockbuster products, adding that companies are expected to keep focusing strategies on areas where they can secure clear market share.
* This article has been translated by AI.
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