A sign of change is showing in the Korean diabetes treatment market, sized at 1 trillion won ($760 million). The catalyst of change is the provision of insurance benefits for the combined use of DPP-4 and SLGT-2 inhibitors.
According to expanded guidelines on the combined treatment for diabetes early this month, medical professionals can additionally prescribe DPP-4 inhibitors for patients administered with metformin and SGLT-2 inhibitors who cannot control their glucose properly.
These two drugs have led the diabetes treatment market recently.
The Korea Diabetes Association has also continuously called for reimbursing the combined use of DPP-4 and SGLT inhibitors.
Therefore, the combined use of the two drugs is highly likely to emerge as a strong prescribing option in clinical fields under the revised reimbursement standards.
Encouraged by the news, some pharmaceutical companies, including LG Chem, Daewoon Pharmaceutical, and Dong-A ST, are busy preparing to release the combined treatment of the two drugs.
Currently, original composites of DPP-4 and SGLT-2 inhibitors include AstraZeneca’s Qtern (saxagliptin-dapagliflozin), MSD’s Steglujan (sitagliptin-ertugliflozin), Boehringer Ingelheim’s Esglito (linagliptin-empagliflozin). These are the composites of each company’s monotherapy, such as Forxiga (dapagliflozin) and Januvia (sitagliptin).
Daewon Pharm is the first Korean company that wins approval for its compound drug. In December 2021, the company won approval for Dapacombi Tab, the composite of DPP-4 inhibitor sitagliptin hydrochloride and SGLT-2 inhibitor dapagliflozin citric acid (undivided). The drug will reportedly be released on the market soon.
About 20 companies have reportedly won product permits based on common ingredients to DongKoo Bio & Pharm at a similar time. Among them are GC Biopharma, Shinpoong Pharm, Hana Pharm, Pharmgen Science, Sam Chun Dang Pharm, Il-Yang Pharm, and Reyon Pharmaceutical.
It is also noteworthy that Ildong Pharma, which had monopolized the marketing of AstraZeneca’s original drug Qtern since the fourth quarter of 2021, won the approval for the composite drug “I Tab” through a bioequivalence study with DongKoo. As a result, Qtern’s sales totaled about 500 million won ($380,000).
LG Chem will release Zemidapa, a gemigliptin-based new diabetes composite treatment, on Saturday. In addition, it added dapagliflozin to its DPP-4 inhibitor gemigliptin. LG Chem plans to hold a symposium for medical professionals in the nation timed with the release of Gemidapa.
Dong-A ST, which has attempted to develop and commercialize a compound drug, also won approval for Suganon from the Ministry of Food and Drug Safety. It is a drug that combines dapagliflozin with its DPP-4 inhibitor, evogliptin.
On the other hand, Jeil Pharm, which had set about to develop a compound drug independently, suspended the development of its candidate substance for an improved new drug, JLP-2005. The move was based on its decision to select and focus on substances that can be commercialized swiftly among its clinical portfolios.
In addition, generic products will jump into the competition timed with the patent expiration of Forxiga on Friday and Januvia in September, heating the competition in the diabetes treatment market further.
According to IQVIA, the sales of Forxiga totaled 45.4 billion won in 2022. Additionally, more than a hundred generic products of Forxiga won approval in January.