Diabetic polyneuritis treatment Dexid (ingredient: r-thioctic acid tromethamine) turned out to be the original drug that won most regulatory approvals for generics development last year among those developed by the domestic pharmaceutical companies, government data showed.
The Ministry of Food and Drug Safety on Wednesday released the number of bioequivalence tests that won the ministry’s approval in 2017.
A bioequivalence test shows the bioavailability of two drugs containing the same active ingredient is statistically equivalent. To carry out a test, drugmakers should get approval for a bioequivalence test plan.
According to the ministry, the government gave the green light to 106 bioequivalence tests last year, down 13.8 percent from 123 cases in 2016.
After obtaining the nod for bioequivalence tests, drugmakers focused on developing generic copies of targeting original drugs whose reevaluation period was over or whose patents expired last year. By treatment type, the companies continued to develop medications for metabolism, the central nervous system, and the circulatory system, last year.
More than half of the bioequivalence test plans approved last year, or 56 cases, aimed to develop generic drugs that targeted originals facing a patent expiration last year.
Among them, diabetic polyneuritis treatment Dexid were related to 13 equivalence tests for generic drug development, which was the most among drug ingredients. Dexid’s reevaluation period expired in November.
Trajenta Duo (linagliptin, metformin hydrochloride), an antidiabetic drug, was targeted in five bioequivalence tests, and hypertension treatment Sevikar HCT (amlodipine besylate, hydrochlorothiazide, olmesartan medoxomil), also in five trials.
By treatment type, development of generic drugs was most active in metabolic treatments (31 cases, 29.2 percent), medicines for the central nervous system diseases such as dementia (16 cases, 15.1 percent), and drugs for the circulatory system disorders such as hypertension (12 cases, 11.3 percent).