Atozet generic’s gold rush unaffected by new regulation

As of Jan. 13, all 21 individual bioequivalence tests approved

Regardless of saturated hyperlipidemia treatment market, follow-ons are rushing after cash cow original

The Korean pharmaceutical industry is keeping a close eye on a series of generics following MSD Korea’s blockbuster combination drug for hyperlipidemia, Atozet (ezetimibe/atorvastatin calcium hydrate), in development with individual bioequivalence test, as the government has enforced new regulation on joint bioequivalence test.

 

Despite the already-saturated statin-ezetimibe combination drug market and increased cost of developing generic with individual bioequivalence test, the industry experts analyze the industry’s needs for the hyperlipidemia treatment generic is still high.

 

According to Ministry of Food and Drug Safety (MFDS) on Jan 13, total 21 cases of bioequivalence test protocols have been cleared for Atozet generics.

 

18 cases were approved last year alone, and additional two cases were approved this year.

 

Expecting Atozet’s post-marketing surveillance (PMS) period to expire on Jan.

 

22 next year, Korean pharmaceutical companies are in a hurry to develop follow-on drugs.

 

The industry has expected many generics would be developed after the blockbuster Atozet generating accumulated prescription sales of 44.8 billion won (according to UBIST) as of third quarter in 2019.

 

21 bioequivalence test protocols have been approved so far proves the drug’s height of popularity.

 

However, some industry insiders once predicted the popularity of Atozet generic development would subside soon as Ministry of Health and Welfare (MOHW) has announced March last year of a plan to lower pricing of generics developed with joint bioequivalence test from July at earliest.

 

The insiders also hinted the ezetimibe-statin combination drug market being excessively saturated with 202 items approved including Atozet, would affect companies developing follow-on drugs.

 

But it turns out those predictions have completely missed the mark.

 

The number of joint bioequivalence tests has dropped due to the revised pricing regulation, but individual companies seem to be conducting their own tests to develop their generics.

 

After nine companies—Medica Korea, Daewoong Bio, Samik Pharm, Ahn-gook Pharmaceutical, Union Korea Pharm, Intro Bio Pharma, Korea Prime Pharm, Hawon Pharm, Youngil Pharm and Wooridul Pharmaceutical—have been approved for joint bioequivalence test on passed Jan.

 

30, no other joint test protocol has been approved.

 

The sudden fall in joint bioequivalence test approval is because Atozet generic can apply for approval listing from Jan.

 

22, 2021 when the original’s PMS expires.

 

But generic based on the joint test would probably take the reduced pricing.

 

Although Wooridul Pharmaceutical and Korea Prime Pharm initially planned to conduct a joint test, they respectively received approval for individual tests on Sept.

 

20 and Jan.

 

10 last year.

 

Individually conducted bioequivalence test is more financially burdening for each company, compare to co-conducted test with two or more companies.

 

Nevertheless, the companies are jumping on to take individual tests with no hesitance as they are running out of the list of potential generic development.

 

A pharmaceutical industry personnel noted, “The number of new generics would descend with the healthcare authority regulating joint bioequivalence test, but markets with popular original would be affected far less.

 

A ten-billion-won worth original with soon expiring exclusivity is getting even rarer these days.

 

So it is not surprising Atozet is attracting many companies to develop follow-on drugs.” Meanwhile, some criticizes Korean pharmaceutical companies blindly developing profitable original’s generic, despite the super-saturated market.