Domestic pharmaceutical companies are actively developing combination drugs, government data showed.
The Ministry of Food and Drug Safety said on Friday it authorized 2,482 medicines last year, with an increased proportion of combo drugs compared to a year earlier.
The 2,046 finished drugs were 1,886 chemical drugs, 28 biopharmaceutical drugs, and 132 herbal medicinal products. They included 11 new chemical medicines, 239 drugs that require data submission, 11 orphan drugs, and 1,625 drugs made by generic and standard manufacturing.
The number of approval for new drugs went down last year, but the development of domestic new medicines and biosimilars remained steady.
The drug regulator granted the license to 15 new drugs last year. Among them, two were developed by domestic firms, and the other 13 were imported. By type, 11 were chemical and four were biopharmaceutical.
The two new drugs by local companies that won approval last year are FutureChem’s Alzavue Inj. and CJ HealthCare’s K-Cab Tab. (ingredient: tegoprazan).
Locally developed incrementally modified drugs (IMDs) that obtained a license in 2018 contain bepotastine salicylate. The IMDs include Belion SR, Tari-S SR, Beposta SR, Bepo-Q, Bepotan SR, and Beporine SR. The IMDs that are biosimilar drugs are Eucept Prefilled Syringe Inj., Eucept Auto Injector Inj., and Nesbell PFS Inj.
Biopharmaceutical new drugs that won approval in 2019 were Sanofi-Aventis Korea’s Dupixent (dupilumab), Janssen Korea’s Tremfya (guselkumab), Shire Pharma Korea’s Gattex Injection (teduglutide), and AstraZeneca Korea’s Imfinzi Injection (durvalumab).
Local drugmakers mainly focused on combination drug development last year.
Among drugs requiring data submission, 111 combo drugs won the nod last year. Among them, 101 were developed by local companies, a whopping 114.8 percent surge compared to 48 in 2017.
Drugs requiring data submission are not new drugs but those in need of the review on the safety and efficacy. They include combo drugs and IMDs.
A majority of drugs requiring data submission were treatments for chronic diseases such as hypertension, hyperlipidemia, and diabetes. Recently, three-in-one medicines for hypertension, hyperlipidemia, and diabetes have steadily obtained a license.
“This is because the incidence of chronic diseases is rising, as Korea became an aged society with the elderly population exceeding 14 percent of the total population in 2017. So, drug companies have aggressively developed combo drugs that help patients take many types of medications at once,” the food and drug safety ministry said.
The number of approved generic drugs, in contrast, has been declining since 2017. Last year, the regulator gave the green light to 982 copy drugs, similar to 954 in 2017.