In the aftermath of the COVID-19, the BA test was disrupted

Medical institutions conducting bioequivalence tests raise possibility of disruption

Korea's Most Performed Yangji Hospital decides to suspend its work by 15th

Pharmaceutical companies are actively conducting bioequivalence tests

COVID-19 infections have also influenced the generic development strategies of pharmaceutical companies.

 

Due to the risk of infection with COVID-19, the bioequivalence task of medical institutions has been disrupted.

 

This is an embarrassing situation for pharmaceutical companies that are conducting bioequivalence tests to reduce drug prices ahead of the reform of the generic drug price system.

 

They are concerned whether the new generics' approval schedule may be delayed or the authorization for drug price maintenance will affect the generic bioequivalence test.

 

According to the industry on the 1st, H Plus Yangji Hospital recently announced the suspension of bioequivalence testing due to the spread of COVID-19 to pharmaceutical companies and analysis agencies.

 

Yangji Hospital has decided to suspend face-to-face testing related to bioequivalence tests, including first-dose monitoring, screening, monitoring, and initiation meeting, by March 15.

 

Tests that have been completed on stage I will proceed normally.

 

Although there were no COVID-19 confirmed patients at the hospital, the company decided to minimize face-to-face work to prevent infection.

 

Yangji Hospital said, “We have made a lot of efforts to conduct a safe test in accordance with the spread of COVID-19, but decided to suspend the work on our own because it is too dangerous”.

 

Yangji Hospital is a medical institution where the largest number of generic bioequivalence tests are conducted in Korea.

 

Last year, 190 of 259 approved bioequivalence studies were performed at Yangji Hospital.

 

Three out of four bioequivalence studies are in charge of Yangji Hospital.

 

Yangji Hospital performed 116 of the 178 approved bioequivalence studies in 2018, accounting for 65.2%.

 

Many medical institutions, except Yangji Hospital, are reportedly conducting bioequivalence testing, such as medication and blood collection.

 

However, if the spread of COVID-19 accelerates in the future, the possibility of business disruption is raised.

 

As a result, pharmaceutical companies are inevitable on generic development strategies.

 

In particular, the development of new generics in preparation for the reform of the drug price system and the strategy of licensed generics may also be affected.

 

The revised drug price plan, which is scheduled to be implemented in July, has the key point that the company must maintain the upper limit of 53.55% compared to the original before the expiration of the patent only when both the bioequivalence test and DMF.

 

Whenever one requirement is not met, the upper limit drops by 15%.

 

In the case of registered generics, the upper limit can be maintained at 53.55% if the bioequivalence test and DMF requirements are met within three years.

 

In the case of new generic drugs, if they do not carry out direct bioequivalence tests, they will receive lower prices than before.

 

The prolonged discontinuation of bioequivalence testing could be a variable in the plan to get higher prices for new generics.

 

There is also same situation with licensed generics.

 

Pharmaceutical companies can maintain their existing high prices only after conducting bioequivalence tests and judging suitability prior to July 2023 for generics licensed under preconditioning.

 

Indeed, pharmaceutical companies are aggressively undertaking bioactivity testing.

 

Approval Status of Monthly Bioequivalence Test Plan (Unit: Case, Source: the Ministry of Food and Drug Safety)

According to the Ministry of Food and Drug Safety, 26 bioequivalence plans approved last month were up 85.7% year-on-year.

 

A total of 44 bioequivalence plans were approved in January and February this year, 13 more than 31 January and February last year.

 

A total of 91 bioequivalence plans were approved in the first half of last year, and increased significantly to 168 in the second half of last year.

 

Licensed generics are actively tested.

 

It is a bioequivalence test for the purpose of changing a manufacturer to produce generics approved by a consignment directly in its own manufacturing facility.

 

If the biopharmaceutical test is conducted with generics produced through the drug product research and the equivalent result is obtained, the drug price reduction can be avoided through the change permit.

 

Some pharmaceutical companies are considering launching bioequivalence trials for as many as tens of generics.

 

The delay in the schedule of bioequivalence due to the spread of COVID-19 is a burden.

 

An official of a pharmaceutical company said, “If the COVID-19 situation is prolonged, and the long-term interruption of bioequivalence testing will affect the generic development strategy and in addition to generics, it is also a concern to conduct normal clinical trials of new or improved drugs”.