(Health Korea News / Lee Chung-man) The government’s policy of lowering the prices of bundled drugs has put the generic companies of ‘Pariet’ (ingredient name: rabeprazole) on high alert.
According to our investigation, Withers Pharmaceuticals has confirmed that it began recruiting participants for the bioequivalence test for its generic version of ‘Pariet’, ‘Raypla’, on the 19th.
The test is to compare the bioequivalence of ‘Pariet’ 20mg and ‘Raeplajeong’ 20mg in a postprandial state with 46 healthy adults. The conducting institution is Central Hospital. The entire schedule includes a one-week washout period and four 2-night, 3-day hospitalizations after screening, until November 6.
‘Rayplajeong’ is a generic of ‘Pariet’, a PPI drug. ‘Pariet’ is a drug that treats gastroesophageal reflux disease and gastric ulcers by inhibiting the proton pump that secretes gastric acid in the gastric wall cells, thereby reducing gastric acid secretion. In Korea, it is manufactured by Geneuwon Science and sold by Korea Eisai.
The domestic patent for ‘Pariet’ expired in December 2008, and currently 276 generic and improved new drugs have been approved. Withers Pharmaceutical’s ‘Raypla’ was approved by the Ministry of Food and Drug Safety for 10 mg in 2007 and 20 mg in 2014.
However, in 2018, when it was discovered that the raw valsartan drug containing impurities was widely used in generic products, the government took action against the contract manufacturing of generic drugs to prevent the indiscriminate proliferation of generic drugs.
This led to the reorganization of the generic drug pricing system in July 2020. The key point is that for generic products, both ① direct bioequivalence testing and ② the use of registered raw pharmaceutical ingredients must be met in order to be recognized as having a drug price of 53.55% of the original price, which is the upper limit for generics.
If you miss a condition, the drug price will be reduced by 15%. If you meet only one of the two conditions, the drug price will be reduced by 45.53%, and if you miss both conditions, the upper limit will be reduced by 38.69%.
Accordingly, companies that have bundled generic versions of ‘Pariet’ have rushed to bioequivalence tests one after another to avoid drug price cuts. ‘Rayplajeong’ is also a twin generic version manufactured at Youngil Pharmaceutical’s Jincheon Plant 1, so Withers Pharmaceutical has started bioequivalence tests for its own production.
The company received approval for a bioequivalence clinical trial plan (IND) comparing ‘Raypra’ and ‘Pariet’ in the fasting state in July 2021, and for a bioequivalence IND comparing them in the fed state in November 2023.
The key is whether Withers Pharmaceuticals succeeds in proving bioequivalence. It is known that after the drug price system reform, many pharmaceutical companies conducted bioequivalence tests, but most failed to prove equivalence, resulting in lower drug prices. According to Ubis, the drug prices of 176 generic products were lowered.
Therefore, attention is focused on whether Withers Pharmaceuticals will be able to successfully demonstrate equivalence in the bioequivalence test.
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Source: www.hkn24.com
