A tough market for new Rosuzet generic

Currently 150 items by 50 companies have been approved with substituting evidence submission

Only seven companies directly manufacture drug, others are consigned

Hanmi Pharmaceutical’s rosuvastatin-ezetimibe combination drug Rosuzet

Although the door for generics is to open next year when the post marketing surveillance (PMS) period is terminated for the rosuvastatin and ezetimibe combination drug treating dyslipidemia, the market annually generating 150 billion won is actually not expecting any new generic.

 

Many of pharmaceutical companies have already received the South Korean health authority by manufacturing drugs on consignments with substituting evidence submission.

 

Only the companies turn the consigned manufacturing to direct manufacturing are conducting bioequivalence test with the reference drug Rosuzet by Hanmi Pharmaceutical after the PMS termination.

 

The Ministry of Food and Drug Safety (MFDS) reported on Nov.

 

9 that the ministry has granted approval for bioequivalence test on only four pharmaceutical companies to confirm body absorption of their drugs compared against Rosuzet.

 

The approved companies are Aprogen Pharmaceuticals, HK inno.N, Korea Prime Pharm and Jeil Pharmaceutical.

 

Aprogen Pharmaceuticals and Korea Prime Pharm did not have approved item by the point of bioequivalence test approval.

 

But the two companies had their products approved recently through their consigned manufacturer by sharing the test result instead of running a direct test.

 

Jeil Pharmaceutical and HK inno.N had already-approved items to receive the bioequivalence test approval.

 

The already-approved products are manufactured on consignments.

 

The bioequivalence test would be conducted to switch to direct manufacturing.

 

Compared to the consigned manufacturing, directly manufacturing the products could raise the profit ratio.

 

It also has an advantage of maintaining the drug pricing by meeting the condition of bioequivalence test result for the pricing reevaluation.

 

HK inno.N is planning to improve the profit ratio of its Rovazet ranked at the third place in the market by conducting a bioequivalence test.

 

Although there are only seven companies in South Korea manufacturing a rosuvastatin plus ezetimibe combination drug, there are 150 approved items by 50 companies.

 

The seven companies include Hanmi Pharmaceutical with the first-listed Rosuzet, Yuhan with Rosuvamibe ranked at the second place, and other companies like Daewon Pharmaceutical, Shin Poong Pharm, Aju Pharm, Alvogen Korea, and Ildong Pharmaceutical.

 

Among those companies, Daewon Pharmaceutical and Shin Poong Pharm are entrusted with manufacturing of the drug by four companies, Aju Pharm by 14 companies and Alvogen Korea by 20 companies.

 

These drugs are technically not a generic.

 

But they are incrementally modified drugs approved with evidence submission.

 

The consigned items have also submitted the identical evidence for approval based on the shared material.

 

Accordingly, the same PMS terms would be applied until June 7.

 

Regardless of the market generating 150 billion won annually, a new generic drug is unlikely to be developed as companies that initially prepared for bioequivalence test rather shared the substituting evidence with other companies and received item approval.

 

The already-listed drug’s pricing is set with a sum of 53.55 percent of each individual drug.

 

So a new generic would not get reduced pricing.

 

However, based on the stepped pricing system, a new generic could receive the lowest pricing when listed later.

 

With 20 same substance drugs already listed since last June, a new applicant drug would be automatically priced at 85 percent of the lower price between the lowest price or 38.69 percent of the upper limit price.

 

Hence, the worst environment for a new generic has been created.

 

The pharmaceutical industry insider commented, “As for the rosuvastatin and ezetimibe combination drug market, too many companies have resorted to sharing the submitted evidence to avoid the stepped pricing.

 

Most of the companies could actually enter the market before the PMS period ends.”