Experts argue that the recent surge in the number of bioequivalence-assured drugs is a reaction to the upcoming new policy to regulate generic drugs. (image: Pixabay)
SEOUL, Jul. 22 (Korea Bizwire) — South Korean pharmaceutical companies are scrambling to produce generic drugs as the government plans to introduce a new policy to prevent unchecked production of generic drugs in the near future.
The companies are attempting to secure as many permits as possible before the new policy kicks in and various regulations, including the one that restricts bioequivalence tests conducted by multiple pharmaceutical companies, take effect.
The Ministry of Food and Drug Safety reported on Sunday that 1,093 bioequivalence-assured drugs have been registered between January and May this year, surpassing last year’s record of 663.
To manufacture and sell generic drugs, a pharmaceutical company should pass the bioequivalence test which proves that the generic drug offers the same effect and safety of the original drug.
Experts argue that the recent surge in the number of bioequivalence-assured drugs is a reaction to the upcoming new policy to regulate generic drugs.
Last February, the ministry decided to introduce a 1+3 policy that limits the maximum number of participants in a joint bioequivalence test, where only one original developer, and three subcontractors can participate.
Once this new policy comes into effect, companies will have to submit bioequivalence test results for each generic drug, which is seen by many as a critical reason behind the recent scramble among pharmaceutical companies to secure as many permits as possible through joint bioequivalence tests.
Many small-to-medium-sized pharmaceutical companies cannot afford bioequivalence tests due to staffing and financial reasons, which is why they partake in joint bioequivalence tests where multiple companies share the cost of the test.
Currently, there are no limits to the number of participants in a joint bioequivalence test.
In addition, a subcontractor can be delegated to produce a drug that is identical to the bioequivalence-assured generic drug it produced in the past without the need to submit any additional documentation.
Experts claim that these practices are the cause of unchecked production of generic drugs in the country.
H. M. Kang (hmkang@koreabizwire.com)
