Pharmas impacted by ‘minoxidil’ bioequivalence test result

Binex received a drug suspension order

Union Korea Pharm makes a second attempt at bioequivalence testing after voluntary withdrawal of a drug

Dongkwang Pharm has completed the submission of bioequivalence test reports for Minoxidil

The bioequivalence re-evaluation of the active ingredient ‘minoxidil’ in comparison to Hyundai Pharm’s

Bioequivalence test outcomes result in different paths for prescription drugs containing the active ingredient ‘minoxidil,’ which was first introduced as a hypertension drug but is now commonly used as a hair-loss drug.

 

The Ministry of Food and Drug Safety (MFDS) recently issued a two-month sales suspension order on Binex’s ‘Bimo Tab 5mg.’ Binex received a notice for ‘Failing to submit the required documents for the 2023 bioequivalence re-evaluation of medicines.’ As a result, the company is banned from selling the item in question from March 11th to May 10th.

 

Although Bimo Tab received a drug suspension settlement, Binex continues attempting bioequivalence test.

 

Binex received approval from the MFDS on February 6th to conduct a bioequivalence study to re-evaluate Bimo Tab and Hyundai Pharm’s 'Minoxidil Tab Hyundai' and has completed patient recruitment.

 

Due to a late start, the company’s submission of equivalence test report may have been delayed.

 

“The delay in the bioequivalence study was due to protocol issues during the preparation process for the equivalence re-evaluation,” a Binex official stated.

 

“Patient recruitment has been completed, and the first phase of blood sampling has been conducted.” The eight products containing the active ingredient minoxidil underwent a re-evaluation for equivalence.

 

These products include Union Korea Pharm’s 'Uni-Minoxidil Tab,' TheU Pharmaceuticals' 'Momosidil Tab,' Medica Korea’s 'Medica-Minoxidil Tab,' Binex’s 'Bimo Tab 5mg,' Auskorea Pharm’s 'Minoxion Tab,' Biopharma’s 'Introminoxidil Tab,' Dae Han New Pharm’s 'DHNP Minoxidil Tab,' and Dongkwang Pharm’s 'Minoxidil Tab 5mg Dongkwang.' DHNP Minoxidil Tab and Medica-Minoxidil Tab were voluntarily withdrawn.

 

Meanwhile, Minoxion Tab and Introminoxidil Tab are currently not in production.

 

Therefore, the four products subjected to equivalence re-evaluation included Minoxidil Tab 5mg Dongkwang, Bimo Tab, Uni-Minoxidil Tab, and Momosidil Tab.

 

Among these, Uni-Minoxidil Tab and Momosidil Tab showed inequivalent compared to Hyundai Pharm’s 'Minoxidil Tab Hyundai' in the bioequivalence test, leading to a recall order for companies on February 7th.

 

Also, Bimo Tab is currently under a suspension of sales order.

 

The only re-evaluated product currently approved for marketing is Minoxidil Tab Dongkwang.

 

The MFDS is reviewing the submitted bioequivalence results report.

 

However, the bioequivalence test for Bimo Tab, which received administrative order, is ongoing.

 

Additionally, Union Korea Pharm is conducting new bioequivalence test for Uni-Minoxidil Tab after a recall, the results of which are currently unknown.

 

Union Korea Pharm received approval from the MFDS on February 21st to conduct bioequivalence test for the Uni-Minoxidil Tab.

 

"After reviewing the bioequivalence report submitted for Uni-Minoxidil, it was found that the drug was not equivalent and had to be recalled.

 

The company revised its bioequivalence test plan and obtained re-approval," an MFDS official stated.

 

The official added, "The bioequivalence re-evaluation will maintain the product's approval status intact, limiting the recall of products already distributed in the market.

 

As the re-evaluation continues, Union Korea Pharm has amended its test plan to conduct bioequivalence test again."