There are many complaints about the revaluation of generics

Submit data such as biological equivalent test results from October to the end of February next year

Delayed schedule due to COVID-19

The authorities are under discussion on the request for an extension of the filing deadline

Pharmaceutical companies complain of unnecessary waste of money on products being sold without problems.

 

Pharmaceutical companies are struggling ahead of the general drug price revaluation.

 

There are many concerns that the biological equivalent test, which was conducted with the aim of maintaining drug prices, could lead to a reduction in drug prices due to delays in submitting data due to COVID-19.

 

The pharmaceutical industry continues to ask health authorities to extend the deadline for submitting data, but it has not yet been carried out.

 

According to the industry on the 25th, the HIRA recently held a briefing session on the revaluation of the upper limit of registered drugs and proposed a schedule to receive revaluation data from October 1st to the end of February next year.

 

The schedule for the generic drug price evaluation announced by the MOHW two years ago has been specified.

 

It announced a plan to reevaluate the upper limit of drugs that maintain the previous drug price by submitting data on conducting biological equivalent test and using registered raw materials drugs by February 28, 2023.

 

This is a follow-up measure to apply the new drug price system, which took effect in July 2020, to the registered generic.

 

In the revised drug price system, generic products can receive an upper limit of 53.55% compared to the original before the patent expires only if they meet both the requirements for direct biological testing and the use of registered raw materials.

 

Each time one requirement is not met, the upper limit is lowered by 15%.

 

Once the pharmaceutical companies' submission of data is completed, they will go through procedures such as practical review and pharmaceutical companies' objections, and from July next year, generic drugs that have not submitted data will be lowered.

 

Requirements for the use of registered raw materials can be met through the replacement of raw material drugs.

 

Pharmaceutical companies are in a situation where they have to choose between accepting drug price cuts or maintaining drug prices through performing biological tests.

 

Pharmaceutical companies are actively developing biological equivalent tests for licensed generics.

 

The goal is to avoid drug price cuts through approval for change by creating generic through pharmaceutical research, conducting biological equivalent tests, and obtaining equivalent results.

 

If the consignment manufacturing is converted to its own manufacturing and the permission is changed, it is using a strategy that meets the requirements of conducting biological equivalent test.

 

However, COVID-19 has recently acted as a variable.

 

Pharmaceutical companies faced difficulties in recruiting subjects as the number of COVID-19 confirmed patients exploded during the biological equivalent test.

 

It is also said that there are frequent situations in which people registered as subjects leave due to COVID-19 confirmation.

 

Due to the lack of subjects, it is inevitably difficult to perform a normal biological equivalent test.

 

Looking at the drug equivalence standard, the biological equivalent test should be conducted on at least 12 people in the test group and the control group, respectively.

 

This means that a biological equivalent test cannot be established unless a total of 24 or more subjects are registered.

 

The test group or control group can be increased by recruiting additional subjects, in which case the biological equivalent test schedule is inevitably delayed.

 

As the requirements for subjects are already strict, the biological equivalent test subjects recruitment difficulties are prolonged.

 

According to the revised pharmaceutical affairs law, which passed the plenary session of the National Assembly in November 2018, only those who have not participated in clinical trials within six months before the test date should be selected as eligible.

 

As it doubled from the previous three months to six months, the number of participants in the biological equivalent test has also decreased significantly.

 

For this reason, pharmaceutical companies have recently asked health authorities to extend the deadline for submitting revaluation data through various channels, but no clear position has been made yet.

 

Oh Chang-hyun, head of the insurance drug division at the MOHW, who attended the briefing session, said, "It is difficult to say for sure because the MFDS has yet to discuss the suspension of data submission." Moreover, pharmaceutical companies are in desperate need of a delay in submitting biological equivalent test data as they have endured a significant reduction in drug prices due to the abandonment of the biological equivalent test by consignment generic.

 

Pharmaceutical companies have inevitably accepted drug price cuts if it is difficult to change the manufacturer of consignment generics by themselves, signaling huge losses.

 

In July 2020, the MFDS officially banned the sale and recovery of non-equivalent products as a result of the biological equivalent test for maintaining drug prices.

 

As a result of the biological equivalent test, the principle was established that measures such as recovery of non-equivalent products will be implemented based on the risk of grade 3.

 

Other consignment products produced at the same manufacturing facility as generic, which has been judged to be unequal, are also likely to be recalled.

 

With trust A supplying the same generics to 10 consignment companies, the logic is that if one of the products is non-equal, the other nine consignment generics may also be suspected of non-conformity.

 

For pharmaceutical companies, they have no choice but to choose to accept the reduction of the drug because the risk they have to take when they start the biological equivalent test is high.

 

It is not possible to try to convert into a company because there are no manufacturing facilities.

 

Many companies cannot convert drugs that require separate factories from other drugs, such as PCNs, hormone drugs, biological drugs, Cephalosporins, and cytotoxic anticancer drugs, because not many companies have manufacturing facilities.

 

Products that require special formulation manufacturing facilities such as soft capsules are also not easy to convert consignment generics' direct production.

 

Pharmaceutical companies continue to complain that the license is an unnecessary waste of money to carry out the biological equivalent test of generic.

 

This is because it is wasteful to conduct biological equivalent tests at a cost to maintain drug prices even though they are already being sold without problems after being recognized for safety and efficacy by the government.